DETAILED ACTION
This Office Action is responsive to the Amendment filed 13 June 2025. Claims 16 - 20 are now pending. The Examiner acknowledges the amendments to claim 16.
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 2 February 2026 has been entered.
Claims 16 - 20 are pending in the instant application.
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 § 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.
Claims 16 – 20 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.
Claim 16, line 7, “carried by the individual patient” is unclear as it is grammatically incorrect and raises the question what is being carried.
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.
Claims 16 and 18 are rejected under 35 U.S.C. 103 as being unpatentable over McAfee et al (US 20200179582 A1, hereinafter McAfee) in view of Reeder et al (US 20020044059 A1, hereinafter Reeder) in further view of Kurosawa et al (US 20140276276 A1, hereinafter “Kurosawa”) in further view of Porras et al (US 20100137693 A1, hereinafter “Porras”).
Regarding claim 16, McAfee teaches a method of treating a patient ([0008]), comprising:
applying a patient medical data apparatus (“automated cell engineering system”, [0058] – [0061], [0065] – [0067], [0071], [0036])
wherein the patient medical data apparatus (“automated cell engineering system”, [0058] – [0061], [0065] – [0067], [0071], [0036]) is also configured to administer medication ([0036]; Examiner interprets cell production as medication, considering what it involves “the cell production (e.g., starting number of cells, type of media, type of activation reagent, type of vector, number of cells or doses to be produced, and the like)” [0036]. );
receiving a first set of physical parameters from the patient medical data apparatus (“automated cell engineering system”, [0058] – [0061], [0065] – [0067], [0071], [0036]) carried (“portable” [0054]) by the individual patient at the point-of-care location (“bedside setting”, abstract, [0020], [0054]) ([0036], [0058], [0067]; Examiner interprets the cell therapy production system (101) comprising a memory which stores cell therapy production system data including patient identification information. See paragraph [0058].; [0102]; [0021]);
receiving blood cells from the individual patient at the point-of-care location (“withdrawing a blood sample from a patient”, [0008]);
applying a cell manufacturing process specific to the individual patient based, at least in part, on the first set of physical parameters (“parameters for the cell production [...] the automated cell engineering system is able to carry out the various automated methods, including methods of producing genetically modified immune cell cultures …”, [0036]) from the patient medical data apparatus at the point-of-care location (“passing the blood sample through a cell separation device to remove a target cell population from the blood sample; transducing the target cell population with a vector to produce a transduced cell culture; optionally expanding the transduced cell culture; harvesting the cell culture; and infusing the harvested cell culture into the patient”, [0008], claim 22, [0025] – [0026], [0102]);
engineering cells using the cell manufacturing process to create a treatment dose for the individual patient at the point-of-care location (“passing the blood sample through a cell separation device to remove a target cell population from the blood sample; transducing the target cell population with a vector to produce a transduced cell culture; optionally expanding the transduced cell culture; harvesting the cell culture; and infusing the harvested cell culture into the patient”, [0008], claim 22, [0025] – [0026]; [0102]); and
administering the treatment dose to the individual patient at the point-of-care location (“injecting or infusing (i.e., slow injection over time) the cell therapy to the patient 102”, [0026]).
McAfee does not teach the apparatus is configured for an individual patient to obtain physical data and physiological data from the individual patient outside of a point-of-care location, engineering cells in response to real-time changes of medical conditions of the individual patient, monitoring the individual patient and an environment of the individual patient using the patient medical data apparatus after administering the treatment dose to the individual patient.
However, Reeder discloses a “patient monitoring system” (abstract) and teaches an apparatus is configured for an individual patient to obtain physical data (“a plurality of devices for sensing various physical conditions and characteristics of the patient” [0013]) and physiological data (“monitoring at least one physiological condition of a patient on a real time basis”, [0012]) from the individual patient outside of a point-of-care location (“a patient or to a bed, cart or other device upon which the patient rests or with which the patient is associated” [0013]; Examiner interprets the apparatus can be on a cart and be wheeled outside of a point-of-care location.), and
monitoring an individual patient using a patient medical data apparatus after administering the treatment dose to the individual patient (“monitoring at least one physiological condition of a patient on a real time basis, means for recording information related to a treatment of the patient and the time that the treatment was given to the patient, and means for determining the effectiveness of the treatment of the patient by further monitoring the physiological conditions on a real time basis after the treatment”, [0012]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of McAfee such that the apparatus is configured for an individual patient to obtain physical data and physiological data from the individual patient outside of a point-of-care location, and monitoring the individual patient using the patient medical data apparatus after administering the treatment dose to the individual patient, as taught by Reeder, for the benefit of “determining whether the patient's condition improves based on the [treatment]” (Reeder: [0121]).
The modified invention of McAfee and Reeder does not teach engineering cells in response to real-time changes of medical conditions of the individual patient and monitoring an environment of the individual patient.
However, Kurosawa discloses “a therapeutic apparatus and a therapeutic method” ([0001]) “which treats fatigue of the whole body” (abstract) and teaches monitoring an environment of an individual patient ([0137], [0144], [0178], [0183] Figure 1).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of McAfee and Reeder to incorporate monitoring an environment of the individual patient, as taught by Kurosawa, for the benefit of providing comfort to the patient (Kurosawa: [0137], [0183]).
The modified invention of McAfee, Reeder and Kurosawa does not teach engineering cells in response to real-time changes of medical conditions of the individual patient.
However, Porras discloses “Methods and apparatus for patient care detect a current medical condition of a patient receiving medical treatment, e.g., by sensing blood pressure, heart rate, weight, glucose level, hemoglobin level, and/or blood potassium level (all by way of example) and transmit information regarding that medical condition to a digital data processing system disposed remotely from the medical treatment apparatus” (abstract) and “processor 104 to determine what content to deliver to the patient 112a during the instant or subsequent treatment” ([0125]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of McAfee, Reeder and Kurosawa such that adjusting the treatment in response to real-time changes of medical conditions of the individual patient, as taught by Porras, for the benefit of providing a safe and necessary treatment to the patient.
Regarding claim 18, McAfee, Reeder, Kurosawa and Porras teach all limitations of claim 16. The modified invention of McAfee, Reeder, Kurosawa and Porras teaches the method further comprising: controlling care of the individual patient based, at least in part, on the cell manufacturing process (McAfee: Figure 1, [0018]) via the patient medical data apparatus (McAfee: “automated cell engineering system 190”, [0058] – [0061], [0065] – [0067], [0071], [0036]) during the cell manufacturing process (McAfee: [0008], claim 22, [0025] – [0026], [0102]).
Claims 17 and 19 are rejected under 35 U.S.C. 103 as being unpatentable over McAfee, Reeder, Kurosawa and Porras, as applied in claim 16, in view of Shi et al (US 20200071670 A1, hereinafter Shi).
Regarding claim 17, McAfee, Reeder, Kurosawa and Porras teach all limitations of claim 16. The modified invention of McAfee, Reeder, Kurosawa and Porras teaches the method further comprising: receiving a second set of physical parameters from the patient medical data apparatus after applying the cell manufacturing process specific to the individual patient (“automatically updated as needed for the various patient feedback and qualities”, [0080] of McAfee; Examiner interprets the parameters are updated after feedback, and thus, reads on this limitation.); and
The modified invention of McAfee, Reeder, Kurosawa and Porras does not teach altering the cell manufacturing process based, at least in part, on the second set of physical parameters from the patient medical data apparatus.
However, Shi discloses “an automated method of producing genetically modified immune cells,” and teaches altering the cell manufacturing process based, at least in part, on the second set of physical parameters from the patient medical data apparatus ([0085] – [0086], [0097], “the cell engineering system automatically adjusts the volume or number of clinical or therapeutic doses produced, based on the input parameters. In some embodiments, the cell engineering system automatically adjusts parameters of the centrifugation (e.g., speed, duration of centrifuging) or filtration (e.g., filter size, volume, duration) based on the pre-defined concentration.”, [0151], [0158]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of McAfee, Reeder, Kurosawa and Porras to incorporate altering the cell manufacturing process based, at least in part, on the second set of physical parameters from the patient medical data apparatus, as taught by Shi, for the benefit of “resulting in cells that have a desired phenotype useful in treating, preventing or ameliorating one or more diseases in an animal, including a human” (Shi: [0081]).
Regarding claim 19, McAfee, Reeder, Kurosawa and Porras teach all limitations of claim 16. The modified invention of McAfee, Reeder, Kurosawa and Porras teaches the method further comprising: selecting or customizing a medical treatment protocol for an the individual patient at the point-of-care location (McAfee: “bedside setting”, abstract, [0020], [0054]) ([0036], [0058], [0067]) (McAfee: “…a user can provide an automated cell engineering system pre-filled with a cell culture and reagents (e.g., an activation reagent, a vector, cell culture media, nutrients, selection reagent, and the like) and parameters for the cell production…”[0036]);
altering the patient medical data apparatus (“automated cell engineering system”, [0058] – [0061], [0065] – [0067], [0071], [0036]) based on the medical treatment protocol at the point-of-care location ([0058] – [0061], [0065] – [0067], [0071], [0036], [0080]);
The modified invention of McAfee, Reeder, Kurosawa and Porras does not teach altering a cell engineering apparatus based on the medical treatment protocol and
manufacturing additional or different treatment doses based on an advancement or deviation from the medical treatment protocol or success of the medical treatment protocol on the individual patient.
However, Shi discloses “an automated method of producing genetically modified immune cells,” and teaches altering a cell engineering apparatus (“enclosed cell engineering system and (a) through (e) are optimized via a process to produce the genetically modified immune cell culture”, [0007]; “optimizing process… via various computer programs and conditions”, [0085]) based on the medical treatment protocol ([0085] – [0086]) and
manufacturing additional or different treatment doses based on an advancement or deviation from the medical treatment protocol or success of the medical treatment protocol on the individual patient ([0007], [00085] – [0086]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of McAfee, Reeder, Kurosawa and Porras to incorporate altering a cell engineering apparatus based on the medical treatment protocol and
manufacturing additional or different treatment doses based on an advancement or deviation from the medical treatment protocol or success of the medical treatment protocol on the individual patient, as taught by Shi, for the benefit of “resulting in cells that have a desired phenotype useful in treating, preventing or ameliorating one or more diseases in an animal, including a human” (Shi: [0081]).
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over McAfee, Reeder, Kurosawa Porras and Shi, as applied in claim 19, in view of Rosenfeld (US 7991625 B2, hereinafter Rosenfeld).
Regarding claim 20, McAfee, Reeder, Kurosawa, Porras and Shi teaches all limitations of claim 19. The modified invention of McAfee, Reeder and Shi teaches individual patients (“individual patients”, [0052]) and the point-of-care location (“bedside setting”, abstract, [0020], [0054]) ([0036], [0058], [0067] of McAfee) but does not teach the method performing in parallel for a plurality of individual patients.
However, Rosenfeld discloses and teaches the method performing in parallel for a plurality of individual patients (“monitored patients, establishes patient-specific rules associated with each of the BCMF monitored patients, and applies the patient-specific rules continuously and simultaneously”, column 6, lines 5 – 13; Examiner interprets multiple patients are monitored as well as applying continuously and simultaneously.)
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of McAfee, Reeder, Kurosawa, Porras and Shi such that the method performing in parallel for a plurality of individual patients, as taught by Rosenfeld, because “the potential for variability in technique between operators can pose an undesirable risk to consistently meeting release criteria and ensuring a safe and dependable product” (Shi: [0046]).
Response to Arguments
Applicant's arguments, filed 2 February 2026, page 8 have been fully considered but they are not persuasive. Regarding claim 16, applicant contends “McAfee does not teach or suggest a PMD apparatus nor use of a first set of physical parameters from the PMD apparatus as defined in the Present Specification. Therefore, McAfee cannot apply cell manufacturing process specific to the individual patient based on the first set of physical parameters from the PDM apparatus located at the point-of-care location.”. However, McAfee discloses “parameters for the cell production [...] the automated cell engineering system is able to carry out the various automated methods, including methods of producing genetically modified immune cell cultures …” ([0036]) and “the automated cell engineering system is able to carry out the various automated methods, including methods of producing genetically modified immune cell cultures, including CAR T-cells, without further input from the user” ([0036]) in which reads on the limitation “applying a cell manufacturing process specific to the individual patient based” in claim 16.
Applicant's arguments, filed 2 February 2026, page 9 have been fully considered but they are not persuasive. Applicant contends “McAfee fails to disclose monitoring individual patient using the patient medical data apparatus after administering the treatment dose to the individual patient and cites Reeder to allegedly make up for the deficiencies of McAfee. The Office Action asserts that Reeder discloses a patient monitoring system that monitors a patient using a PMD apparatus after administering the treatment dose and asserts that it would have been obvious to one of ordinary skill in the art to modify McAfee with Reeder to incorporate a PMD apparatus after administering the treatment does for the benefit of determining whether the patient's condition improves based on the therapy as per paragraph [0121] of Reeder. The Applicant respectfully disagrees.”.
However, McAfee and Reeder are in the same endeavor and it would be obvious to combine. See MPEP 2143.IA.
Applicant's arguments, filed 2 February 2026, page 10 have been fully considered but they are not persuasive. Applicant contends “the combination of McAfee and Reeder is completely silent as to monitoring the individual patient and an environment of the individual patient using the patient medical data apparatus after administering the treatment dose to the individual patient at the point-of- care location as found in independent claim 16 and its dependent claims.”.
However, the combination of McAfee and Reeder teaches the limitation, considering Reeder discloses “monitoring at least one physiological condition of a patient on a real time basis, means for recording information related to a treatment of the patient and the time that the treatment was given to the patient, and means for determining the effectiveness of the treatment of the patient by further monitoring the physiological conditions on a real time basis after the treatment” (Reeder: [0012]).
Applicant's arguments, filed 2 February 2026, page 11 have been fully considered but they are not persuasive. Applicant disagrees “it would have been obvious to modify the method of McAfee and Reeder to incorporate monitoring an environment of the individual patient for the benefit of providing comfort to the patient”.
However, McAfee, Reeder and Kurosawa are in the same endeavor and Kurosawa teaches monitoring an environment of an individual patient ([0137], [0144], [0178], [0183] Figure 1). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of McAfee and Reeder to incorporate monitoring an environment of the individual patient, as taught by Kurosawa, for the benefit of providing comfort to the patient (Kurosawa: [0137], [0183]). See MPEP 2143.IA. Additionally, Shi discloses “the cell engineering system automatically adjusts the volume or number of clinical or therapeutic doses produced, based on the input parameters. In some embodiments, the cell engineering system automatically adjusts parameters of the centrifugation (e.g., speed, duration of centrifuging) or filtration (e.g., filter size, volume, duration) based on the pre-defined concentration.”([0151]) ([0085] – [0086], [0097], [0158]), which the “automatically adjusts” reads on “second set of physical parameters” as found in claim 17. For the benefit of “resulting in cells that have a desired phenotype useful in treating, preventing or ameliorating one or more diseases in an animal, including a human” (Shi: [0081]), Shi is combined with the modified invention of McAfee, Reeder, Kurosawa and Porras.
Applicant's arguments, filed 2 February 2026, page 15, have been fully considered but they are not persuasive. Applicant contends “none of the cited references can then teach modifying an PMD apparatus that is not disclosed in any of the references”. However, Shi discloses “the cell engineering system automatically adjusts the volume or number of clinical or therapeutic doses produced, based on the input parameters. In some embodiments, the cell engineering system automatically adjusts parameters of the centrifugation (e.g., speed, duration of centrifuging) or filtration (e.g., filter size, volume, duration) based on the pre-defined concentration.” ([0151], [0158]; “the optimizing process is a self-adjusting process, that is one that does not require input from an external (human) user, and is able via various computer programs and conditions to determine the required modifications to a cell culture or other characteristics to optimize the automated process”, [0085] – [0086], [0097]).
Applicant’s arguments with respect to claim(s) 16 – 20 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. See rejection above.
Applicant's arguments, filed 2 February 2026, page 16 have been fully considered but they are not persuasive. Applicant contends “the PMD apparatus cannot be altered based on the medial treatment protocol that was selected or customized at the point of care location”. However, the combination of McAfee, Reeder and Shi discloses this, considering , Shi discloses “the cell engineering system automatically adjusts the volume or number of clinical or therapeutic doses produced, based on the input parameters. In some embodiments, the cell engineering system automatically adjusts parameters of the centrifugation (e.g., speed, duration of centrifuging) or filtration (e.g., filter size, volume, duration) based on the pre-defined concentration.” ([0151], [0158]; “the optimizing process is a self-adjusting process, that is one that does not require input from an external (human) user, and is able via various computer programs and conditions to determine the required modifications to a cell culture or other characteristics to optimize the automated process”, [0085] – [0086], [0097]). The self-adjusting process reads on applicant’s argument “altered based on the medial treatment protocol that was selected or customized at the point of care location”. See rejection above.
Applicant's arguments, filed 2 February 2026, page 18 have been fully considered but they are not persuasive. Regarding claim 20, applicant contends “Rosenfeld only discloses a monitoring system that provides messages from a remote location. Rosenfeld does not disclose any type of remote controlling of PMD apparatus or altering processes of cell engineering apparatus for a plurality of patients, let alone manufacturing additional or different treatment doses for each of those patients”. However, since the modified invention of McAfee, Reeder and Shi discloses controlling a PMD apparatus (see rejection above), it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of McAfee, Reeder and Shi such that the method performing in parallel for a plurality of individual patients, as taught by Rosenfeld, because “the potential for variability in technique between operators can pose an undesirable risk to consistently meeting release criteria and ensuring a safe and dependable product” (Shi: [0046]).
Applicant’s arguments with respect to claim(s) 16 – 20 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. See rejection above.
Conclusion
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/JULIE THI TRAN/Examiner, Art Unit 3791
/ALEX M VALVIS/Supervisory Patent Examiner, Art Unit 3791