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 .
Notice to Applicant
This communication is in response to the amendment filed 02/18/2026. Claims 31, 38, 45 have been amended. Claim 57 has been canceled. Claims 31, 33-56, 59-62 are presented for examination.
Subject Matter Free of Prior Art
Claim(s) 31, 33-56, 59-62 are allowable over prior art because the prior art of record fail to expressly teach or suggest, either alone or in combination, the features found within the independent claims, in particular: “providing, via a computing device, a patient registration portal to enable hospital personnel at a hospital facility to securely register the patient, assign a unique patient identifier to the patient, submit a product order request including an order identifier which is associated with the patient identifier, and/or select a manufacturing facility for manufacturing a cell therapy product comprising expanded T cells from a biological sample of the patient, wherein information relating to the patient, and the product order request is stored in a central database, wherein the product order request further comprises a preliminary schedule of manufacturing process for the cell therapy product and a preliminary schedule of patient treatment events, wherein the patient treatment events comprise one or more of: lymphodepletion, infusion of the cell therapy product, leukapheresis, IL-2 administration, tumor resection, and inpatient stay; providing, via the computing device, a tumor procurement portal including a smart checklist configured to facilitate the hospital personnel to safely extract the biological sample from the patient, associate the biological sample with the order identifier, and create a record of a procedure for extracting the biological sample including a record of a chain of custody and a chain of identity of the biological sample and inventory of materials used during the procedure, the tumor procurement portal enabling the hospital personnel to generate a label for a container for the extracted biological sample, the label comprising the order identifier, wherein data entered into the smart checklist, by the hospital personnel, when performing the procedure is stored and/or updated to the central database,” “performing one or more quality control assays on at least a portion of the cell therapy product at a first time point and at a second time point subsequent to the first time point during the multi-step cell expansion process, to obtain acceptance parameters for the expanded population of T cells at corresponding time points, the acceptance parameters comprising one or more of viability, sterility, cell count, mycoplasma count, CD3+ cell count, a result of an endotoxin assay, and a result of a Gram stain assay; if the acceptance parameters, obtained at one or more time points during the manufacturing process, do not meet an acceptance criteria, modifying the preliminary schedule of manufacturing process to generate an updated manufacturing schedule and completing the manufacturing of the cell therapy product in accordance with the updated manufacturing schedule.” Because the prior art does not teach or disclose the above features in the specific manner and combinations recited in independent claim 31, claim 31 is hereby deemed to be allowable over prior art. Originally numbered dependent claims 33-56, 59-62 incorporate the allowable features of originally numbered independent claim 31, through dependency.
However, the claims are still rejected under 101.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim(s) 31, 33-56, 59-62 is/are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding claim 31, the phrase "optionally" renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Claim(s) 33-56, 59-62 is/are rejected as being dependent on claim 31.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 31, 33-56, 59-62 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more. Based upon consideration of all of the relevant factors with respect to the claims as a whole, the claims are directed to non-statutory subject matter which do not include additional elements that are sufficient to amount to significantly more than the judicial exception because of the following analysis:
Claim 31 is drawn to a method which is within the four statutory categories (i.e., method).
Independent claim 31 recites manufacturing a cell therapy product by expanding a population of cells obtained from a tumor from a patient into the cell therapy product, the manufacturing comprising: providing…a patient registration portal to enable hospital personnel at a hospital facility to securely register the patient, assign a unique patient identifier to the patient, submit a product order request including an order identifier which is associated with the patient identifier, and/or select a manufacturing facility for manufacturing a cell therapy product comprising expanded T cells from a biological sample of the patient, wherein information relating to the patient, and the product order request is stored…, wherein the product order request further comprises a preliminary schedule of manufacturing process for the cell therapy product and a preliminary schedule of patient treatment events, wherein the patient treatment events comprise one or more of: lymphodepletion, infusion of the cell therapy product, leukapheresis, IL-2 administration, tumor resection, and inpatient stay; providing…a tumor procurement portal including a smart checklist configured to facilitate the hospital personnel to safely extract the biological sample from the patient, associate the biological sample with the order identifier, and create a record of a procedure for extracting the biological sample including a record of a chain of custody and a chain of identity of the biological sample and inventory of materials used during the procedure, the tumor procurement portal enabling the hospital personnel to generate a label for a container for the extracted biological sample, the label comprising the order identifier, wherein data entered into the smart checklist, by the hospital personnel, when performing the procedure is stored and/or updated…; maintaining…the record of the chain of custody and the chain of identity while securely receiving the biological sample shipped from the hospital facility; …; …; if the acceptance parameters, obtained at one or more time points during the manufacturing process, do not meet an acceptance criteria, modifying the preliminary schedule of manufacturing process to generate an updated manufacturing schedule and completing the manufacturing of the cell therapy product in accordance with the updated manufacturing schedule; providing…a manufacturing portal to record data relating to the preliminary schedule of manufacturing process, or the updated manufacturing schedule, and the quality control assays including the record of the chain of custody and the chain of identity…, the data relating to the quality control assays including acceptance parameters obtained at the first and second time points; providing…a logistics portal to generate labels for containers used during the preliminary schedule of manufacturing process, or the updated manufacturing schedule, and containers for shipping the manufactured cell therapy product to the hospital facility, the labels including the unique patient identifier and the order identifier; coordinating…a schedule of shipping with the preliminary schedule of manufacturing process, or the updated manufacturing schedule, and exchanging the record of the chain of custody and the chain of identity records; optionally modifying the preliminary schedule of patient treatment events to generate an updated schedule of patient treatment events, in accordance with one or more of: the updated manufacturing schedule, changes in availability of the patient, the hospital facility, and/or the hospital personnel, and changes in the schedule of shipping; …; and generating…a report for an end-to-end process from extraction of the biological sample from the patient to infusion of the manufactured cell therapy product into the patient, the report including the record of the chain of custody and the chain of identity.
Under its broadest reasonable interpretation, the limitations noted above, as drafted, covers certain methods of organizing human activity (i.e., managing personal behavior or relationships or interactions between people…following rules or instructions), but for the recitation of generic computer components. That is, other than reciting a “computing device,” the claim encompasses rules or instructions followed to manage the workflow of a manufacturing process (i.e., registering, recordkeeping, scheduling). If a claim limitation, under its broadest reasonable interpretation, covers managing personal behavior or relationships or interactions between people, but for the recitation of generic computer components, then it falls within the “Certain Methods of Organizing Human Activity” grouping of abstract ideas. Accordingly, the claims recite an abstract idea.
Claim 1 recites additional elements (i.e., computing device; central database; in accordance with the preliminary schedule of manufacturing process, expanding a population of T cells from the biological sample by a multi-step cell expansion process in a closed system bioreactor at the manufacturing facility; performing one or more quality control assays on at least a portion of the cell therapy product at a first time point and at a second time point subsequent to the first time point during the multi-step cell expansion process, to obtain acceptance parameters for the expanded population of T cells at corresponding time points, the acceptance parameters comprising one or more of viability, sterility, cell count, mycoplasma count, CD3+ cell count, a result of an endotoxin assay, and a result of a Gram stain assay; treating the patient by infusion of the cell therapy product, according to the preliminary schedule of patient treatment events, or optionally the updated schedule of patient treatment events). Looking to the specifications, a computing device with a central database is described at a high level of generality (¶ 002211-002214), such that it amounts to no more than mere instructions to apply the exception using generic computer components. Also, although the claims recites the additional elements of “in accordance with the preliminary schedule of manufacturing process, expanding a population of T cells from the biological sample by a multi-step cell expansion process in a closed system bioreactor at the manufacturing facility,” “performing one or more quality control assays on at least a portion of the cell therapy product at a first time point and at a second time point subsequent to the first time point during the multi-step cell expansion process, to obtain acceptance parameters for the expanded population of T cells at corresponding time points, the acceptance parameters comprising one or more of viability, sterility, cell count, mycoplasma count, CD3+ cell count, a result of an endotoxin assay, and a result of a Gram stain assay,” “treating the patient by infusion of the cell therapy product, according to the preliminary schedule of patient treatment events, or optionally the updated schedule of patient treatment events,” adding the steps of cell expansion, quality control assays, and treating a patient to a process that recites managing the workflow of a manufacturing process (i.e., registering, recordkeeping, scheduling) does not add a meaningful limitation to the process of managing the workflow of a manufacturing process (i.e., registering, recordkeeping, scheduling), and as such, amounts to insignificant extrasolution activity (i.e., post-solution activity). See: MPEP § 2106.05(g). The additional elements do not integrate the abstract idea into a practical application because they do not impose any meaningful limits on practicing the abstract idea. Looking at the limitations as an ordered combination adds nothing that is not already present when looking at the elements individually. Accordingly, the claims are directed to an abstract idea.
Reevaluated under step 2B, the additional elements noted above do not provide “significantly more” when taken either individually or as an ordered combination. As previously analyzed, the use of a general purpose computer or computers (i.e., computing device with a central database) does not impose any meaningful limitation on the computer implementation of the abstract idea, so it does not amount to significantly more than the abstract idea. Also, although the claims recites the additional elements of “in accordance with the preliminary schedule of manufacturing process, expanding a population of T cells from the biological sample by a multi-step cell expansion process in a closed system bioreactor at the manufacturing facility,” expanding cells has been recognized by the present specification as well understood, routine, and conventional elements/functions (¶ 00324, i.e., “The expansion methods described herein generally use culture media with high doses of a cytokine, in particular IL-2, as is known in the art”; ¶ 00501; ¶ 00796, i.e., “TILs are expanded in gas-permeable containers. Gas-permeable containers have been used to expand TILs using PBMCs using methods, compositions, and devices known in the art”; ¶ 0797, i.e., “Such containers, devices, and methods are known in the art and have been used to expand TILs”). Also, although the claims recites the additional elements of “performing one or more quality control assays on at least a portion of the cell therapy product at a first time point and at a second time point subsequent to the first time point during the multi-step cell expansion process, to obtain acceptance parameters for the expanded population of T cells at corresponding time points, the acceptance parameters comprising one or more of viability, sterility, cell count, mycoplasma count, CD3+ cell count, a result of an endotoxin assay, and a result of a Gram stain assay,” performing quality control assays on cell therapy product has been recognized by the present specification as well understood, routine, and conventional elements/functions (¶ 00277, i.e., “a cell viability assay can be performed after the second expansion (including expansions referred to as the REP expansion), using standard assays known in the art”; ¶ 00789-00790). Also, although the claims recites the additional elements of “treating the patient by infusion of the cell therapy product, according to the preliminary schedule of patient treatment events, or optionally the updated schedule of patient treatment events,” treating the patient by infusion of the cell therapy product has been recognized by the present specification as well understood, routine, and conventional elements/functions (¶ 00146, i.e., “The TILs (including, in some cases, genetically engineered TILs) can be administered by using infusion techniques that are commonly known in immunotherapy (see, e.g., Rosenberg, et al., New Eng. J of Med 1988, 319, 1676)”). Looking at the limitations as an ordered combination adds nothing that is not already present when looking at the elements individually. The combination of elements does not indicate a significant improvement to the functioning of a computer or any other technology and their collective functions merely provide a conventional computer implementation of the abstract idea. Furthermore, the additional elements or combination of elements in the claims, other than the abstract idea per se, amount to no more than a recitation of generally linking the abstract idea to a particular technological environment or field of use, as the courts have found in Parker v. Flook; similarly, the current invention merely limits the claimed calculations to the healthcare industry which does not impose meaningful limits on the scope of the claim. Therefore, there are no limitations in the claims that transform the judicial exception into a patent eligible application such that the claims amount to significantly more than the judicial exception.
Dependent claims 33-56, 59-62 include all the limitations of the parent claims and further elaborate on the abstract idea discussed above and incorporated herein.
Claims 34-56, 59-60 further define the analysis and organization of data for the performance of the abstract idea and do not recite any additional elements. Thus, the claims do not integrate the abstract idea into a practical application and do not provide “significantly more.”
Claims 33 further recites the additional elements of “a customer relationship management (CRM) database,” respectively, which are described at a high level of generality, such that it amounts to no more than mere instructions to apply the exception using generic computer components and only generally links the use of a judicial exception to a particular technological environment or field of use, which does not impose meaningful limits on the scope of the claim. Also, functional limitations further define the analysis and organization of data for the performance of the abstract idea. Looking at the limitations as an ordered combination adds nothing that is not already present when looking at the elements individually. Thus, the claim as a whole do not integrate the abstract idea into a practical application and do not provide “significantly more.”
Claims 61-62 further recites the additional elements of “wherein the expanded T cells comprise tumor infiltrating lymphocytes (TILs)” and “wherein the TILs comprise genetically modified TILs,” respectively, which still does not add a meaningful limitation to the process of managing the workflow of a manufacturing process (i.e., registering, recordkeeping, scheduling), and as such, amounts to insignificant extrasolution activity. See: MPEP § 2106.05(g). Reevaluated under step 2B, treating the patient by infusion of “genetically modified TILs” has been recognized by the present specification as well understood, routine, and conventional elements/functions (¶ 00146, i.e., “The TILs (including, in some cases, genetically engineered TILs) can be administered by using infusion techniques that are commonly known in immunotherapy (see, e.g., Rosenberg, et al., New Eng. J of Med 1988, 319, 1676)”). Looking at the limitations as an ordered combination adds nothing that is not already present when looking at the elements individually. Thus, the claim as a whole do not integrate the abstract idea into a practical application and do not provide “significantly more.”
Although the dependent claims add additional limitations, they only serve to further limit the abstract idea by reciting limitations on what the information is and how it is received and used. These information characteristics do not change the fundamental analogy to the abstract idea grouping of “Certain Methods of Organizing Human Activity,” and, when viewed individually or as a whole, they do not add anything substantial beyond the abstract idea. Furthermore, the combination of elements does not indicate a significant improvement to the functioning of a computer or any other technology. Therefore, the claims when taken as a whole are ineligible for the same reasons as the independent claims.
Response to Arguments
Applicant's arguments filed 02/18/2026 have been fully considered but they are not persuasive. Applicant’s arguments will be addressed hereinbelow in the order in which they appear in the response filed 02/18/2026.
In the remarks, Applicant argues in substance that:
Regarding the 112(b) rejections, the amendments overcome the rejections.
Regarding the 101 rejections,
“The pending claims recite at least steps of manufacturing a cell therapy product, performing quality control assays of the cell therapy product, modifying the manufacturing process according to the results of the quality control assays, and treating the patient with the manufactured cell therapy product in accordance with the scheduled or modified patient treatment events. Thus, the pending claims are not directed to an abstract idea”; and
“the pending claims contain various meaningful limitations which separate the claims from an abstract idea. For example, the pending claims recite limitations on the types of patient treatment events for a cell therapy product comprising expanded T cells, plus whether and how to modify a preliminary schedule of such patient treatment events. Other limitations on how to modify a manufacturing process are also specified tailored for the cell therapy product. A skilled artsian would have understood that the pending claims do not refer to a general, abstact idea, but containin meaning limitations for performing the claimed invention…a technical problem exists in order to streamline the manufacturing, administration and patient hospitalization processes so that a patient can receive a complete treatment as soon as possible. The instant invention, as reflected in the pending claims, provides dynamic processes starting from registering patients, scheduling and performing manufacturing process (and modifying it if necessary) to treating patients under the scheduled (or modified) treatment events. Such processes contribute to collaboration among multiple facilities… Therefore, a skilled artisan would understand that the pending claims refer to a practical solution, rather than merely administrative solution, to a technical problem.”
It is respectfully submitted that Examiner has considered Applicant’s arguments and does not find them persuasive. Examiner has attempted to address all of the arguments presented by Applicant; however, any arguments inadvertently not addressed are not persuasive for at least the following reasons:
In response to Applicant’s argument that (a) regarding the 112(b) rejections, the amendments overcome the rejections:
It is respectfully submitted that Examiner withdraws the aforementioned 112(b) rejections of Office Action dated 09/08/2025 because the amendments have rendered the rejections moot. However, the amended claims give rise to other 112(b) rejections, as addressed in the above Office Action.
In response to Applicant’s argument that (b) regarding the 101 rejections,
“The pending claims recite at least steps of manufacturing a cell therapy product, performing quality control assays of the cell therapy product, modifying the manufacturing process according to the results of the quality control assays, and treating the patient with the manufactured cell therapy product in accordance with the scheduled or modified patient treatment events. Thus, the pending claims are not directed to an abstract idea”:
It is respectfully submitted that per broadest reasonable interpretation of the claim in light of the specification, the claims of the present invention encompass the activity of (to paraphrase) rules or instructions followed to manage the workflow of a manufacturing process (i.e., registering, recordkeeping, scheduling), which covers the sub-grouping of managing personal behavior or relationships or interactions between people in the “Certain Methods of Organizing Human Activity” grouping of abstract ideas. Put another way, the claimed invention amounts to a series of rules or steps that a user would follow to register information, establish and maintain relationships between records, and generate labels, schedules, and reports. This is an abstract idea. That the steps are performed on one or more well-known, general purpose computer (i.e., a computing device with a central database) does not remove the invention from being directed to an abstract idea.
Applicant argues “The pending claims recite at least steps of manufacturing a cell therapy product, performing quality control assays of the cell therapy product, modifying the manufacturing process according to the results of the quality control assays, and treating the patient with the manufactured cell therapy product in accordance with the scheduled or modified patient treatment events. Thus, the pending claims are not directed to an abstract idea.” However, the claim limitations to which Applicant seem to refer as “modifying the manufacturing process according to the results of the quality control assays” (i.e., “if the acceptance parameters, obtained at one or more time points during the manufacturing process, do not meet an acceptance criteria, modifying the preliminary schedule of manufacturing process to generate an updated manufacturing schedule and completing the manufacturing of the cell therapy product in accordance with the updated manufacturing schedule”) are interpreted as rules or instructions followed to manage the workflow of a manufacturing process (i.e., registering, recordkeeping, scheduling), which is the abstract idea. Furthermore, the claim limitations to which Applicant seem to refer as “manufacturing a cell therapy product, performing quality control assays of the cell therapy product, modifying the manufacturing process according to the results of the quality control assays, and treating the patient with the manufactured cell therapy product in accordance with the scheduled or modified patient treatment events” (i.e., “in accordance with the preliminary schedule of manufacturing process, expanding a population of T cells from the biological sample by a multi-step cell expansion process in a closed system bioreactor at the manufacturing facility; in accordance with the preliminary schedule of manufacturing process, expanding a population of T cells from the biological sample by a multi-step cell expansion process in a closed system bioreactor at the manufacturing facility, by a multi-step cell expansion process performed in a closed system bioreactor at the manufacturing facility, at least a portion of the population of cells to obtain the cell therapy product; performing one or more quality control assays on at least a portion of the cell therapy product at a first time point and at a second time point subsequent to the first time point during the multi-step cell expansion process, to obtain acceptance parameters for the expanded population of T cells at corresponding time points, the acceptance parameters comprising one or more of viability, sterility, cell count, mycoplasma count, CD3+ cell count, a result of an endotoxin assay, and a result of a Gram stain assay,” “treating the patient by infusion of the cell therapy product, according to the preliminary schedule of patient treatment events, or optionally the updated schedule of patient treatment events”) are interpreted as additional elements, which do not add a meaningful limitation to the process of managing the workflow of a manufacturing process (i.e., registering, recordkeeping, scheduling), and as such, amounts to insignificant extrasolution activity (i.e., post-solution activity). See: MPEP § 2106.05(g). Looking at the limitations as an ordered combination adds nothing that is not already present when looking at the elements individually.
Thus, the claims are directed to an abstract idea.
“the pending claims contain various meaningful limitations which separate the claims from an abstract idea. For example, the pending claims recite limitations on the types of patient treatment events for a cell therapy product comprising expanded T cells, plus whether and how to modify a preliminary schedule of such patient treatment events. Other limitations on how to modify a manufacturing process are also specified tailored for the cell therapy product. A skilled artsian would have understood that the pending claims do not refer to a general, abstact idea, but containin meaning limitations for performing the claimed invention…a technical problem exists in order to streamline the manufacturing, administration and patient hospitalization processes so that a patient can receive a complete treatment as soon as possible. The instant invention, as reflected in the pending claims, provides dynamic processes starting from registering patients, scheduling and performing manufacturing process (and modifying it if necessary) to treating patients under the scheduled (or modified) treatment events. Such processes contribute to collaboration among multiple facilities… Therefore, a skilled artisan would understand that the pending claims refer to a practical solution, rather than merely administrative solution, to a technical problem”:
Applicant argues “the pending claims contain various meaningful limitations which separate the claims from an abstract idea. For example, the pending claims recite limitations on the types of patient treatment events for a cell therapy product comprising expanded T cells, plus whether and how to modify a preliminary schedule of such patient treatment events. Other limitations on how to modify a manufacturing process are also specified tailored for the cell therapy product.” However, Applicant fails to specify the claim limitations to which Applicant refer. Regardless, the claim limitations to which Applicant seem to refer as “limitations on the types of patient treatment events for a cell therapy product comprising expanded T cells, plus whether and how to modify a preliminary schedule of such patient treatment events. Other limitations on how to modify a manufacturing process are also specified tailored for the cell therapy product” (i.e., “wherein the product order request further comprises a preliminary schedule of manufacturing process for the cell therapy product and a preliminary schedule of patient treatment events, wherein the patient treatment events comprise one or more of: lymphodepletion, infusion of the cell therapy product, leukapheresis, IL-2 administration, tumor resection, and inpatient stay,” “if the acceptance parameters, obtained at one or more time points during the manufacturing process, do not meet an acceptance criteria, modifying the preliminary schedule of manufacturing process to generate an updated manufacturing schedule and completing the manufacturing of the cell therapy product in accordance with the updated manufacturing schedule,” “optionally modifying the preliminary schedule of patient treatment events to generate an updated schedule of patient treatment events, in accordance with one or more of: the updated manufacturing schedule, changes in availability of the patient, the hospital facility, and/or the hospital personnel, and changes in the schedule of shipping”) are interpreted as rules or instructions followed to manage the workflow of a manufacturing process (i.e., registering, recordkeeping, scheduling), which is the abstract idea, and not additional elements to be interpreted in Step 2A, Prong Two. Looking at the limitations as an ordered combination adds nothing that is not already present when looking at the elements individually.
Applicant argues “a technical problem exists in order to streamline the manufacturing, administration and patient hospitalization processes so that a patient can receive a complete treatment as soon as possible. The instant invention, as reflected in the pending claims, provides dynamic processes starting from registering patients, scheduling and performing manufacturing process (and modifying it if necessary) to treating patients under the scheduled (or modified) treatment events. Such processes contribute to collaboration among multiple facilities… Therefore, a skilled artisan would understand that the pending claims refer to a practical solution, rather than merely administrative solution, to a technical problem.” However, “streamline the manufacturing, administration and patient hospitalization processes” addresses an administrative problem, and not a technical problem to any specific devices, technology, or computers for that matter, and thus, the claims do not provide a technical solution.
Examiner cannot find any problem caused by the technological environment to which the claims are confined, which per broadest reasonable interpretation of the claim in light of the specification, is a well-known, general purpose computer. The computing system did not cause the argued problem and thus it is not a technical problem caused by the technological environment to which the claims are confined. While the specification need not explicitly set forth the improvement, the disclosure does not provide sufficient details such that one of ordinary skill in the art would recognize the claimed invention as providing any technical improvement or any physical improvement to the computer. See MPEP § 2106.04(d)(1) and 2106.05(a).
Furthermore, the claim limitations to which Applicant seem to refer as “registering patients, scheduling and…modifying [manufacturing process] if necessary” are interpreted as rules or instructions followed to manage the workflow of a manufacturing process (i.e., registering, recordkeeping, scheduling), which is the abstract idea, and not additional elements to be interpreted in Step 2A, Prong Two. Also, although the claims recites the additional elements of “in accordance with the preliminary schedule of manufacturing process, expanding a population of T cells from the biological sample by a multi-step cell expansion process in a closed system bioreactor at the manufacturing facility,” “treating the patient by infusion of the cell therapy product, according to the preliminary schedule of patient treatment events, or optionally the updated schedule of patient treatment events,” adding the steps of cell expansion and treating a patient to a process that recites managing the workflow of a manufacturing process (i.e., registering, recordkeeping, scheduling) does not add a meaningful limitation to the process of managing the workflow of a manufacturing process (i.e., registering, recordkeeping, scheduling), and as such, amounts to insignificant extrasolution activity (i.e., post-solution activity). See: MPEP § 2106.05(g). Looking at the limitations as an ordered combination adds nothing that is not already present when looking at the elements individually
Even if the claims provide the alleged improvements of “collaboration among multiple facilities,” any alleged benefits of the invention are at best, an improvement to the abstract idea (i.e., rules or instructions followed to manage the workflow of a manufacturing process (i.e., registering, recordkeeping, scheduling)). However, an improved abstract idea is still an abstract idea.
Thus, the claim as a whole does not integrate the recited judicial exception into a practical application.
Reevaluated under step 2B, the additional elements noted above do not provide “significantly more” when taken either individually or as an ordered combination. Looking at the limitations as an ordered combination adds nothing that is not already present when looking at the elements individually. Thus, the claim as a whole does not amount to significantly more than the judicial exception.
Thus, Examiner maintains the 101 rejections of claims 31, 33-56, 59-62, which have been updated to address Applicant’s remarks and to comply with the 2019 Revised Patent Subject Matter Eligibility Guidance and the 2024 Guidance Update on Patent Subject Matter Eligibility, Including on Artificial Intelligence in the above Office Action.
Conclusion
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 extension fee 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 date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Emily Huynh whose telephone number is (571)272-8317. The examiner can normally be reached on M-Th 8-5 PM.
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/EMILY HUYNH/Primary Examiner, Art Unit 3683