DETAILED ACTION
Status of Claims
This is a Final Office Action in response to the arguments and/or amendments filed on 23 October 2025.
Claim(s) 1 is/are amended.
Claim(s) 1-18 is/are currently pending and have been examined.
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) 1-4 and 8-18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Dedry et al. (US 2015/0307829 A1) in view of Balazs et al. (WO 2015/079273 A1) and Pfleger et al. (US 2022/0374816 A1).
Regarding Claim 1: Dedry discloses a mobile processing laboratory configured for facilitating performing therewithin a cell therapy process (Recent technological and scientific progresses have made it possible to develop Advanced Therapy Medicinal Products (ATMPs), including medicinal products that contain viable human cells that, by engrafting in patient's tissues, can restore specific physiological functions that are deficient in the patient. These innovative products, also called Cell Therapy Medicinal Products or Cell-Based Medicinal Products (CTMPs or CBMPs; Vamvakas S et al., 2011). See at least [0003]. Also: The present disclosure provides a novel facility for formulating CBMPs in sites where said product is administered to a patient and that are distinct and away from the site where a bulk CBMP preparation is initially prepared and validated according to Good Manufacturing Practices. Such a facility, hereafter named as Mobile CBMP Formulation Facility (MCF Facility) allows an efficient access and distribution of CBMPs in medical sites in particular at those devoid of equipment, personnel, and/or areas dedicated to similar activities. See at least [0008]), the mobile processing laboratory comprising:
a portable enclosure (a unitary structure comprising equipment and working spaces. See at least [0020]).
a bio-isolator comprising a processing chamber for carrying out one or more activities associated with the performance of said cell therapy processes, comprising: one or more pieces of laboratory equipment for carrying out the cell therapy process and being housed within said enclosure (A First Unit (Unit 1) that is a working space designed and equipped to allow operators to store, count, test, sample, formulate, and/or package cell preparations and produce Cell-Based Medicinal Product formulations according to Good Manufacturing Practices. See at least [0009]. Also: In a specific embodiment, Unit 1 comprises two or more Working Areas, each one dedicated to activities for formulating and validating CBMPs. In particular, Unit 1 comprises: (i) A First Working Area that is equipped with a vertical laminar air flow connected to Unit 3 and with instruments for manipulating, sampling, formulating, and/or packaging of Cell-Based Medicinal Products; (ii) A Second Working Area that is equipped with instruments for counting and/or testing cell preparations; and (iii) A Third Working Area that is equipped for storing cell preparations and/or equipment to be used within Unit 1. See at least [0011]. Also: Working Area 1.1.B can be further isolated from the rest of Unit 1 by a glove-box that is operated from outside. See at least [0055]).
a plurality of sensors, each configured to measure information regarding the environment, cellular material of the process, and/or one of said pieces of laboratory equipment (Regarding the type and arrangement of devices for monitoring the status of MCF Facility and of operations that are performed within (on site or remotely), sensors, video or photo cameras, and any other appropriate instrument can be used for monitoring and possibly transferring the data and/or images that have been acquired in specific locations to instruments in Unit 3, Unit 4, and/or any other different location that may trigger further actions automatically (e.g. adapting temperature or alerting operators that an equipment is not working or located properly). In particular, appropriate sensors may register air quality (by indicating concentration of specific gases or the concentration of particles below or above a given size), air pressure, security problems, chemical or biological contamination, temperature, or humidity within any of Unit 1, Unit 2, Unit 5, and/or Unit 3.. See at least [0056]).
a computer system configured for management of said cell therapy process, said computer system being configured to: facilitate collecting data from said sensors; and manage said cell therapy process based on data collected from one or more mobile processing laboratories configured for performing therewithin the cell therapy process (A Second Working Area can be also equipped with a computer for monitoring, storing, elaborating, and transmitting data that are generated by operators and equipment within Unit 1. See at least [0012]. Also: The Second Working Area (FIG. 3B and FIG.
impurity of a chemical or microbiological nature, or foreign matter that have been unintentionally introduced into CBMP formulation during production, sampling, packaging, storage, or transportation). It is equipped with a laboratory bench with sufficient surface to operate (e.g. a cleanable, metal or plastic surface) onto which instruments for counting or otherwise measuring and/or testing, cell preparations are positioned appropriately, as well as a computer for acquiring, elaborating, storing, and transmitting data to enable a satisfactory control of GMP operations. See at least [0059]. Also: In-process Quality control operations for monitoring (and, if necessary adjusting) the process and ensuring that CBMP formulation conforms to its specification are performed in Second Working Area (1.2; FIGS. 3A, 3B and 3E). See at least [0070]).
Dedry does not explicitly disclose a plurality of processing chambers or a plurality of buffer chambers configured in selective communication to at least one of the plurality of processing chambers.
Balazs teaches a plurality of processing chambers or a plurality of buffer chambers configured in selective communication to at least one of the plurality of processing chambers (The layout of the glove box system is illustrated in Figure 5. The glove box system 26, 27 of unique design installed in the container comprises two glove box segments and the transfer boxes 28 interconnecting them, a total of 5 elements. See at least Page 9 Lines 23-25 and Figure 5).
Dedry teaches a mobile laboratory that utilizes a single chamber isolator, upon which the claimed invention’s use of a multi-chamber isolator can be seen as an improvement. However, Balazs demonstrates that the prior art already knew of multi-chamber isolators for biological processing within a mobile laboratory (The invention relates to a highly mobile container laboratory. Balazs Abstract). One of ordinary skill in the art could have trivially substituted Balazs’ isolator into the system of Dedry. Further, one of ordinary skill in the art would have recognized that such a substitution would have predictably resulted in a system which could process multiple samples simultaneously (See at least Balazs’ Page 3 and 9). As such, the identified substitution would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention in view of the disclosures of Dedry and the teachings of Balazs.
Dedry does not expressly disclose optimizing said one or more activities based on data collected from said sensors and one or more other mobile processing laboratories configured for performing therewithin substantially the same cell therapy process.
Pfleger teaches optimize one or more activities based on data collected from sensors and one or more other processing laboratories (in a laboratory with 10 automated instruments, 2 automated sample preparation systems, and 2 automated sample transfer systems, the computing system or sample scheduler might determine the appropriate warm-up times, runtimes, transfer times, operation times, and/or the like, for all these instruments and systems, and might identify the optimal coordination and schedule for operating the 10 automated instruments, 2 automated sample preparation systems, and 2 automated sample transfer systems, to account for warm-up times for each instrument or system, the time samples are prepared, the time it takes to transfer the samples from one location to another, the available use times for each instrument, and/or the like. In this manner, optimized coordination and scheduling of use of equipment and resources within the laboratory may be achieved. See at least [0073]. Also: determining the pre-processing time involved with performance of the first task using the first equipment (at block 406) might comprise determining, with the computing system, a pre-processing time involved with performance of the first task using the first equipment using at least one of a moving average algorithm, a linear regression algorithm, a Grubbs outlier test, a Chauvenet's criterion test, a Pierce's criterion test, or a Dixon's Q test on at least one of historical and current data regarding pre-processing times for performance of the first task on similar equipment. See at least [0104]).
Dedry and Balazs suggests a mobile cell-based medical product laboratory which manages the processes performed therein, upon which the claimed invention’s optimization of such processes based on data collected from processing sites can be seen as an improvement. However, Pfleger demonstrates that the prior art already knew of optimizing the processes of a laboratory based on data collected regarding the performance of a task on such equipment. One of ordinary skill in the art could have easily applied the techniques of Pfleger to the mobile laboratory of Dedry and Balazs by optimizing the mobile laboratory’s processes using data collected for similar equipment in another mobile laboratory. One of ordinary skill in the art would have recognized that such an application of Pfleger would have resulted in an improved laboratory that would more efficiently implement its processes . As such the application of Pfleger, and the claimed invention, would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention in view of the disclosures of Dedry and the teachings of Balazs and Pfleger.
Regarding Claim 2: Dedry in view of Balazs and Pfleger makes obvious the above limitations. Pfleger further teaches wherein said other mobile processing laboratories are configured for performing the cell therapy process on equipment substantially the same as said laboratory equipment (determining the pre-processing time involved with performance of the first task using the first equipment (at block 406) might comprise determining, with the computing system, a pre-processing time involved with performance of the first task using the first equipment using at least one of a moving average algorithm, a linear regression algorithm, a Grubbs outlier test, a Chauvenet's criterion test, a Pierce's criterion test, or a Dixon's Q test on at least one of historical and current data regarding pre-processing times for performance of the first task on similar equipment. See at least [0104]).
Regarding Claim 3: Dedry in view of Balazs and Pfleger makes obvious the above limitations. Pfleger further teaches wherein the computer system is configured to perform the optimization based on a machine learning algorithm (in some instances, at least one of determining the core processing time, determining the pre-processing time, or determining the post-processing time may be performed using at least one of an AI system, a machine learning system, a learning algorithm-based system, or a neural network system, and/or the like, to enhance computational processing by the computing system. See at least [0022]). The motivation to combine Dedry, Balazs and Pfleger is the same as explained under claim 1 above, and is incorporated herein.
Regarding Claim 4: Dedry in view of Balazs and Pfleger makes obvious the above limitations. Additionally, Dedry discloses wherein said one or more activities comprises management of rate of usage of said laboratory equipment (in a laboratory with 10 automated instruments, 2 automated sample preparation systems, and 2 automated sample transfer systems, the computing system or sample scheduler might determine the appropriate warm-up times, runtimes, transfer times, operation times, and/or the like, for all these instruments and systems, and might identify the optimal coordination and schedule for operating the 10 automated instruments, 2 automated sample preparation systems, and 2 automated sample transfer systems, to account for warm-up times for each instrument or system, the time samples are prepared, the time it takes to transfer the samples from one location to another, the available use times for each instrument, and/or the like. In this manner, optimized coordination and scheduling of use of equipment and resources within the laboratory may be achieved. See at least [0073]).
Regarding Claim 8: Dedry in view of Balazs and Pfleger makes obvious the above limitations. Additionally, Dedry discloses wherein said one or more activities comprises management of coordination between said laboratory equipment (in a laboratory with 10 automated instruments, 2 automated sample preparation systems, and 2 automated sample transfer systems, the computing system or sample scheduler might determine the appropriate warm-up times, runtimes, transfer times, operation times, and/or the like, for all these instruments and systems, and might identify the optimal coordination and schedule for operating the 10 automated instruments, 2 automated sample preparation systems, and 2 automated sample transfer systems, to account for warm-up times for each instrument or system, the time samples are prepared, the time it takes to transfer the samples from one location to another, the available use times for each instrument, and/or the like. In this manner, optimized coordination and scheduling of use of equipment and resources within the laboratory may be achieved. See at least [0073]).
Regarding Claim 9: Dedry in view of Balazs and Pfleger makes obvious the above limitations. Additionally, Dedry discloses wherein said at least some of said laboratory equipment is selected from a group including a bio-isolator, a cell manufacturing system, a biosafety cabinet, an incubator, a cell counting device, a microscope, an electroporator, an image analyzer, a refrigerator, a freezer, a liquid nitrogen tank, a sonication device, a UV chamber, a light table, a stereoscope, a shaking incubator, a peristaltic pump, a particle sampler, a sealer, a welder, a cell processing system, a centrifuge, a pipettor, a vortex mixer, and an X-ray irradiator (Such equipment may comprise commercial closed systems for separating, manufacturing, and/or formulating cell preparations and other biological products under sterile conditions in a more or less automated manner like Sepax, Elutra Cell Separation System, or CliniMACS Prodigy, pumps, incubators for cooling/heating materials at a given temperature, a sealing unit (e.g. Hematron, Fenwal Inc.), sensors, and other auxiliary equipment that can be validated for use in GMP conditions. See at least [0058]).
Regarding Claim 10: Dedry in view of Balazs and Pfleger makes obvious the above limitations. Additionally, Dedry discloses wherein at least some of the process sensors are selected from a group including a dissolved oxygen sensor, a pH sensor, a process sensor, a lactate-glucose sensor, a temperature sensor, a metabolic sensor, a biomass sensor, an optical sensor, and a pressure sensor (Such equipment may comprise commercial closed systems for separating, manufacturing, and/or formulating cell preparations and other biological products under sterile conditions in a more or less automated manner like Sepax, Elutra Cell Separation System, or CliniMACS Prodigy, pumps, incubators for cooling/heating materials at a given temperature, a sealing unit (e.g. Hematron, Fenwal Inc.), sensors, and other auxiliary equipment that can be validated for use in GMP conditions. See at least [0058]).
Regarding Claim 11: Dedry in view of Balazs and Pfleger makes obvious the above limitations. Additionally, Dedry discloses wherein at least some of the environmental sensors are selected from a group including a temperature sensor, a humidity sensor, a pressure, and a particle counter (appropriate sensors may register air quality (by indicating concentration of specific gases or the concentration of particles below or above a given size), air pressure, security problems, chemical or biological contamination, temperature, or humidity within any of Unit 1, Unit 2, Unit 5, and/or Unit 3).
Regarding Claim 12: Dedry in view of Balazs and Pfleger makes obvious the above limitations. Additionally, Dedry discloses the interior of said enclosure being divided into two or more rooms (See at least Fig. 2C).
Regarding Claim 13: Dedry in view of Balazs and Pfleger makes obvious the above limitations. Additionally, Dedry discloses a first of said rooms being connected by a doorway to the exterior of the mobile processing laboratory and maintained at a higher ambient pressure (See at least Fig. 2C, noting unit 2 indicated as having a door to exterior, and the arrow indicating air flow from unit 2 to exterior), and a last of said rooms being connected by a doorway to an adjacent room and maintained at a higher ambient pressure (See at least Fig. 2C, noting unit 1 indicated as having a door to unit 1, and the arrow indicating air flow from unit 1 to unit 5).
Regarding Claim 14: Dedry in view of Balazs and Pfleger makes obvious the above limitations. Additionally, Dedry discloses the interior of the enclosure being further divided into additional rooms, each being connected by doorways to two of said rooms, said doorways defining a path between said first and last rooms (See at least Fig. 2, noting units 2, 5, and 1), wherein each room is maintained at an ambient pressure which is higher than that of a room adjacent thereto being closer along said path to said first room (See at least Fig. 2, noting the arrow indicating air flow from unit 1 to unit 5, and from unit 5 to unit 2).
Regarding Claim 15: Dedry in view of Balazs and Pfleger makes obvious the above limitations. Additionally, Dedry discloses wherein said laboratory equipment is housed within said last room (A First Unit (Unit 1) that is a working space designed and equipped to allow operators to store, count, test, sample, formulate, and/or package cell preparations and produce Cell-Based Medicinal Product formulations according to Good Manufacturing Practices. See at least [0009]. Also: In a specific embodiment, Unit 1 comprises two or more Working Areas, each one dedicated to activities for formulating and validating CBMPs. In particular, Unit 1 comprises: (i) A First Working Area that is equipped with a vertical laminar air flow connected to Unit 3 and with instruments for manipulating, sampling, formulating, and/or packaging of Cell-Based Medicinal Products; (ii) A Second Working Area that is equipped with instruments for counting and/or testing cell preparations; and (iii) A Third Working Area that is equipped for storing cell preparations and/or equipment to be used within Unit 1. See at least [0011]).
Regarding Claim 16: Dedry in view of Balazs and Pfleger makes obvious the above limitations. Additionally, Dedry discloses an auxiliary laboratory equipment housed in at least one room other than said last room (A Third Unit (Unit 3) that is adjacent to Unit 1 and that houses the equipment for exchanging of electric power, air, and/or data with Unit 1, Unit 2. See at least [0009]).
Regarding Claim 17: Dedry in view of Balazs and Pfleger makes obvious the above limitations. Additionally, Dedry discloses being configured for connection to one or more externally supplied infrastructure services (when MCF Facility is on site, Unit 3 and/or Unit 4 can be plugged to public or private electricity, water, and or gas networks. See at least [0053]).
Regarding Claim 18: Dedry in view of Balazs and Pfleger makes obvious the above limitations. Additionally, Dedry discloses wherein said infrastructure services comprise one or more selected from a group including electric power, water supply, drainage, and gas supply (when MCF Facility is on site, Unit 3 and/or Unit 4 can be plugged to public or private electricity, water, and or gas networks. See at least [0053]).
Claim(s) 5-7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Dedry et al. (US 2015/0307829 A1) in view of Balazs et al. (WO 2015/079273 A1) and Pfleger et al. (US 2022/0374816 A1), and further in view of Tuysuzoglu et al. (US 2022/0214368 A1).
Regarding Claim 5: Dedry in view of Balazs and Pfleger makes obvious the above limitations. Dedry does not expressly disclose wherein said one or more activities comprises management of supply chain logistics. Tuysuzoglu teaches one or more activities comprises management of supply chain logistics (Flexible optimization systems and methods according to embodiments of this disclosure are configured to optimize such lab test assignments across a large number of laboratory analyzers, which may also be referred to as instruments and/or machines. See at least [0016]. Also: Embodiments of the optimization systems and methods may advantageously provide one or more of the following five features: reduced turn-around-time (TAT), load balancing, efficient reagent usage, lower quality assurance costs, and/or improved system robustness. Reducing TAT can increase throughput, staying within limits of service-level agreements, and responding to time-sensitive requests. Providing a balanced load across each laboratory analyzer can improve overall TAT and reduce excessive analyzer wear-out. Reagents may be added to test samples to help determine, measure, or identify a characteristic or condition of the test sample (e.g., measure an amount of glucose or other analyte in a blood sample). Reagents are usually a large cost associated with diagnostic laboratory operations. Thus, optimizing reagent use may be a priority in some laboratory operations. Also, each laboratory analyzer goes through quality control and calibration procedures that incur both time and costs. Thus managing the use of laboratory analyzers for optimal efficiency leads to lower quality assurance costs and time efficiency. And ensuring robustness of the entire laboratory setup increases the likelihood that all requested testing can be completed even in the event of one or more laboratory analyzer being offline, such as for maintenance or repair. See at least [0017]).
Dedry, Balazs and Pfleger suggests a mobile cell-based medical product laboratory which optimizes itself based on collected data, upon which the claimed invention’s optimization of supply chain logistics can be seen as an improvement. However, Tuysuzoglu demonstrates that the prior art already knew of optimizing of activities associated with supply chain logistics. One of ordinary skill in the art could have easily applied the techniques of Tuysuzoglu to the mobile laboratory of Dedry, Balazs, and Pfleger by optimizing the mobile laboratory’s processes according to Tuysuzoglu’s reagent usage management. One of ordinary skill in the art would have recognized that such an application of Pfleger would have resulted in an improved laboratory that would more efficiently utilize its resources. As such the application of Tuysuzoglu, and the claimed invention, would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention in view of the disclosures of Dedry and the teachings of Balazs, Pfleger and Tuysuzoglu.
Regarding Claim 6: Dedry in view of Balazs and Pfleger makes obvious the above limitations. Dedry does not expressly disclose wherein said one or more activities comprises management of maintenance of said laboratory equipment. Tuysuzoglu teaches one or more activities comprises management of maintenance of said laboratory equipment (Flexible optimization systems and methods according to embodiments of this disclosure are configured to optimize such lab test assignments across a large number of laboratory analyzers, which may also be referred to as instruments and/or machines. See at least [0016]. Also: Embodiments of the optimization systems and methods may advantageously provide one or more of the following five features: reduced turn-around-time (TAT), load balancing, efficient reagent usage, lower quality assurance costs, and/or improved system robustness. Reducing TAT can increase throughput, staying within limits of service-level agreements, and responding to time-sensitive requests. Providing a balanced load across each laboratory analyzer can improve overall TAT and reduce excessive analyzer wear-out. Reagents may be added to test samples to help determine, measure, or identify a characteristic or condition of the test sample (e.g., measure an amount of glucose or other analyte in a blood sample). Reagents are usually a large cost associated with diagnostic laboratory operations. Thus, optimizing reagent use may be a priority in some laboratory operations. Also, each laboratory analyzer goes through quality control and calibration procedures that incur both time and costs. Thus managing the use of laboratory analyzers for optimal efficiency leads to lower quality assurance costs and time efficiency. And ensuring robustness of the entire laboratory setup increases the likelihood that all requested testing can be completed even in the event of one or more laboratory analyzer being offline, such as for maintenance or repair. See at least [0017]).
Dedry, Balazs, and Pfleger suggests a mobile cell-based medical product laboratory which optimizes itself based on collected data, upon which the claimed invention’s optimization of equipment maintenance can be seen as an improvement. However, Tuysuzoglu demonstrates that the prior art already knew of optimizing of activities associated with equipment maintenance. One of ordinary skill in the art could have easily applied the techniques of Tuysuzoglu to the mobile laboratory of Dedry, Balazs, and Pfleger by optimizing the mobile laboratory’s processes according to equipment usage balancing. One of ordinary skill in the art would have recognized that such an application of Pfleger would have resulted in an improved laboratory that would more efficiently utilize its resources. As such the application of Tuysuzoglu, and the claimed invention, would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention in view of the disclosures of Dedry and the teachings of Balazs, Pfleger, and Tuysuzoglu.
Regarding Claim 7: Dedry in view of Balazs and Pfleger makes obvious the above limitations. Dedry does not expressly disclose wherein said one or more activities comprises management of replacement of said laboratory equipment. Tuysuzoglu teaches one or more activities comprises management of replacement of said laboratory equipment (Flexible optimization systems and methods according to embodiments of this disclosure are configured to optimize such lab test assignments across a large number of laboratory analyzers, which may also be referred to as instruments and/or machines. See at least [0016]. Also: Embodiments of the optimization systems and methods may advantageously provide one or more of the following five features: reduced turn-around-time (TAT), load balancing, efficient reagent usage, lower quality assurance costs, and/or improved system robustness. Reducing TAT can increase throughput, staying within limits of service-level agreements, and responding to time-sensitive requests. Providing a balanced load across each laboratory analyzer can improve overall TAT and reduce excessive analyzer wear-out. Reagents may be added to test samples to help determine, measure, or identify a characteristic or condition of the test sample (e.g., measure an amount of glucose or other analyte in a blood sample). Reagents are usually a large cost associated with diagnostic laboratory operations. Thus, optimizing reagent use may be a priority in some laboratory operations. Also, each laboratory analyzer goes through quality control and calibration procedures that incur both time and costs. Thus managing the use of laboratory analyzers for optimal efficiency leads to lower quality assurance costs and time efficiency. And ensuring robustness of the entire laboratory setup increases the likelihood that all requested testing can be completed even in the event of one or more laboratory analyzer being offline, such as for maintenance or repair. See at least [0017]).
Dedry, Balazs, and Pfleger suggests a mobile cell-based medical product laboratory which optimizes itself based on collected data, upon which the claimed invention’s optimization of equipment replacement can be seen as an improvement. However, Tuysuzoglu demonstrates that the prior art already knew of optimizing of activities associated with equipment replacement. One of ordinary skill in the art could have easily applied the techniques of Tuysuzoglu to the mobile laboratory of Dedry, Balazs, and Pfleger by optimizing the mobile laboratory’s processes according to equipment usage balancing. One of ordinary skill in the art would have recognized that such an application of Pfleger would have resulted in an improved laboratory that would more efficiently utilize its resources. As such the application of Tuysuzoglu, and the claimed invention, would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention in view of the disclosures of Dedry and the teachings of Balazs, Pfleger, and Tuysuzoglu.
Response to Arguments
Applicant’s Argument Regarding 101 Rejections of claims 1-18: Applicant submits that these additional elements integrate the alleged exception into a practical application under MPEP 2106.04.
Examiner’s Response: Applicant's arguments filed 23 October 2025 have been fully considered and they are persuasive. MPEP 2106.04(d) notes that implementing an abstract idea with or using a particular machine has been found by the courts as indicative an abstract idea having been integrated into a practical application. Here, Applicant’s claim requiring “a bio-isolator comprising a plurality of processing chambers … a plurality of buffer chambers configured in selective communication to at least one of the plurality of processing chambers” excludes typical isolators with a single processing chamber and a single buffer chamber, and as such should be considered a “particular machine.” Further, per MPEP 2106.04(d), “Step 2A specifically excludes consideration of whether the additional elements represent well-understood, routine, or conventional activity.” Therefore, even if such isolators are conventional, that fact does not exclude them from constituting a “particular machine” and integrating the abstract idea into a practical application at Step 2A Prong Two. As such Examiner concludes that this additional element integrates the abstract idea into a practical application, and thus the claims are directed to patent eligible subject matter.
Applicant’s Argument Regarding 103 Rejections of claims 1-18: Dedry does not teach or suggest the presently claimed “a bio-isolator comprising a plurality of processing chambers for carrying out one or more activities associated with the performance of said cell therapy process; a plurality of buffer chambers configured in selective communication to at least one of the plurality of processing chambers.”
Examiner’s Response: Applicant's arguments filed 23 October 2025 have been fully considered but they are rendered moot by the amendment of claim 1.
Additional Considerations
The prior art made of record and not relied upon that is considered pertinent to applicant’s disclosure can be found in the PTO-892 of the prior office action dated 23 April 2025.
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 Bion A Shelden whose telephone number is (571)270-0515. The examiner can normally be reached M-F, 12pm-10pm EST.
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/Bion A Shelden/Primary Examiner, Art Unit 3685 2025-11-10