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 .
Status
Claims 1-20 have been examined.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
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Claim 1 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 12230378 Although the claims at issue are not identical, they are not patentably distinct from each other because both claims recite to receive and transmit patient information and a cell order request for manufacturing the cell therapy product from a population of cells obtained from a tumor resected from a patient, the patient information including a patient-specific identifier, and the cell order request including a cell order identifier; to determine a schedule for patient treatment events based on an estimated completion date for obtaining of the cell therapy product manufactured by and received from a manufacturing facility; to generate a manufacturing label for a manufacturing container to be used in a process for manufacturing the cell therapy product from at least a portion of the population of cells using a cell expansion technique; to receive a plurality of acceptance parameters for the cell therapy product at a plurality of time points during the process for manufacturing the cell therapy product; verify a chain of custody and a chain of identity based on the cell order identifier and the patient-specific identifier on the manufacturing label at corresponding subsequent time points. The claims differ in that claim 1 of current application recites , whereas claims 1, 4, of US Patent No. 12230378 recite a cpopulatiobn of cells obtained from a tumor resected from the patient, generating a warning signal, etc…
Claim 1 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 12159700. Although the claims at issue are not identical, they are not patentably distinct from each other because both claims recite manufacturing of a cell therapy product for treating cancer.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
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 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.
Claim(s) 1-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Susarchick et al. (WO2019055896A1 hereinafter Susarchick) in view of Gruenberg ( US 20030175242A1) and further in view of.June et al. (US. 20030099643A1).
With respect to claim 1, Susarchic teaches a system for coordinating manufacturing of a cell therapy product for treating cancer, the system comprising:
a hospital-side subsystem comprising at least one computing device and configured to:
receive and transmit patient information and a cell order request for manufacturing the cell therapy product from a population of cells obtained from a tumor resected from a patient, the patient information including a patient-specific identifier, and the cell order request including a cell order identifier (‘896; Abstract: the computing device generates a patient-specific identifier associated with the cell order request. The computing device initiates a process to create transfected T cells for infusion into the patient's bloodstream…The computing device records a tracking event for each step, including the patient-specific identifier, to generate a chain of custody of the patient's T cells), and
determine a schedule for patient treatment events based on an estimated completion date for obtaining of the cell therapy product manufactured by and received from a manufacturing facility (‘896; Para 0132: FIG. 4B depicts the material delivery site confirmation screen; FIG. 4C depicts the screen to open the appointment scheduler; and FIG. 4D depicts the appointment scheduler. In some embodiments, the user interface module 108a communicates with a remote computing device of the manufacturing facility, in conjunction with the database 1 10, to coordinate scheduling of the biological material modification to ensure the most efficient processing schedule so that the modified material is returned quickly back to the patient.);
a manufacturing subsystem comprising at least one computing device and configured to:
generate a manufacturing label for a manufacturing container to be used in a process for manufacturing the cell therapy product from at least a portion of the population of cells using a cell expansion technique, the manufacturing label comprising the cell order identifier, the patient-specific identifier, and information associated with the process for manufacturing and quality of the cell therapy product (‘242; Para 0106: Source material collected from a subject is placed in the labeled source bag (step 136), also referred to as a “parent” source bag and transported to the central processing facility 140. Upon arrival at the central processing facility 140, a central processing facility administrator logs in the “parent” source bag (step 142). The central processing facility 140 also is under the control of the same manufactures. As a result, it can be controlled by the same permits, so that, for example in the United States, it is administered under the same single government license as the satellite facility. The parent source bag is scanned and an identifiable label, such as a GUID barcode label that is identical to the GUID barcode label on the “parent” source bag, is generated as part of the log-in procedure. Next, the label, such as a barcode label, is printed and used to label a “child” source bag (step 144), thereby tracking the material.),
initiate and control the process of manufacturing the cell therapy product (‘242; Abstract: processing the source material from the first subject at the central processing facility to produce a therapy product for administration to the same first subject, transporting the therapy product back to the satellite facility and administering the therapy product to the same first subject. All steps are performed under the control of the manufacturer.; Para 0022: for producing and distributing somatic cell and gene therapy products so that all steps of the processes are under the control of a manufacturer from vein-to-vein. Such methods and systems should meet current and future regulatory guidelines in the United States and other jurisdictions. The methods and systems for producing and distributing somatic cell and gene therapy products permit manufacture under conditions that meet CGMP under a single manufacturing license).
It would have been obvious to one of ordinary skill in the art before the effective filing dates of claimed invention to modify the system of Susarchick with the technique of manufacturing and distributing somatic cell therapy and gene therapy products as taught by Grueberg and the motivation is to provide manufacturing label of cell therapy product in the chain-of-custody for manufacturing process.
,June teaches
receive a plurality of acceptance parameters for the cell therapy product at a plurality of time points during the process for manufacturing the cell therapy product (‘643; Para 0029: FIG. 19 depicts CD28 + T cell expansion following stimulation with anti-CD3 monoclonal antibody coated beads and anti-CD28 antibody, B7-1, B7-2, B7-1 and B7-2, or control CHO-neo cells at different time points after stimulation.; Para 0030: FIG. 20 depicts CD28 + T cell expansion following stimulation with PMA and anti-CD28 antibody, B7-1, B7-2, B7-1 and B7-2, or control CHO-neo cells at different time points after stimulation.).
generate an updated manufacturing label corresponding to each of the plurality of time points comprising updated information associated with quality of the cell therapy product, the updated information being based on the plurality of acceptance parameters at a corresponding time point and whether the plurality of acceptance parameters met acceptance criteria (‘643; Para 0029, Para 0030).
It would have been obvious to one of ordinary skill in the art before the effective filing dates of claimed invention to modify the system of Susarchick/Grueberg with the technique of proliferation of t cells as taught by June and the motivation is to provide acceptance parameters in the chain-of-custody for manufacturing process.
Susarchick in view of Gruenberg and June teaches
read the updated manufacturing label at each subsequent time point, and
verify a chain of custody and a chain of identity based on the cell order identifier and the patient-specific identifier on the manufacturing label at corresponding subsequent time points (‘896; Para 0140: FIGS. 5A and 5B are exemplary screenshots generated by the user interface module 108a to enable the client computing devices 102a-102d to view the chain of custody associated with a particular patient, biological material, and cell modification process. As shown in FIG. 5A, the chain of custody of the biological material during the leukapheresis process (including the steps of scheduling the procedure, completing the procedure, and having the extracted T cells ready for shipment) is captured in a timeline at the top of the screen, where each step of the leukapheresis process is associated with a point on the timeline, and the chain of custody of the biological material during the delivery process (e.g., T cells shipped from extraction site, T cells delivered to manufacturing facility) is captured in a timeline at the bottom of the screen. When the event tracking module 108b and chain of custody module 108c record a tracking event as described above, the user interface module 108a traverses the chain of custody data structure to graphically represent the current status of the chain of custody on screen.); and
logistics subsystem comprising at least one computing device and configured to:
transmit a shipping request to a logistics facility based on a shipping schedule received from the hospital-side subsystem and/or the manufacturing subsystem (‘896; Para 0052: the database 1 10 may comprise an enterprise business suite that manages the data for the server computing device 106 and includes modules to enable chain-of-custody and chain-of-identity tracking and logistics for the biological sample; Para 0136), and
verify the chain of custody and the chain of identity based on the cell order identifier and the patient-specific identifier (‘896; Para 0006: The techniques described herein provide the specific technical advantage over existing systems of providing a continuous and automatic chain of custody and chain of identity for a patient-specific biological sample during an immunotherapy procedure, to create a computerized information portal that interested parties— such as the patient, physician, manufacturer, and other medical personnel).
Claim 4 is rejected as the same reason with claim 1.
With respect to claim 2, the combined art teaches the system of claim 1, wherein the manufacturing subsystem is further configured to: determine a preliminary schedule of manufacturing including a set of dates corresponding to a plurality of time points, including a first time point and a second time point subsequent to the first time point, for determining whether the plurality of acceptance parameters for the cell therapy product meet acceptance criteria during the process for manufacturing the cell therapy product depending on the cell expansion technique being used and when a cell order request is received at the manufacturing facility; and determine a shipping schedule for shipping the cell therapy product based on the preliminary schedule of manufacturing (‘896: As shown in FIG. 5A, the chain of custody of the biological material during the leukapheresis process (including the steps of scheduling the procedure, completing the procedure, and having the extracted T cells ready for shipment) is captured in a timeline at the top of the screen, where each step of the leukapheresis process is associated with a point on the timeline).
With respect to claim 3, the combined art teaches the system of claim 1, wherein the manufacturing system is further configured to generate a warning signal if:the patient-specific identifier on the updated manufacturing label for a subsequent manufacturing step does not match the patient-specific identifier on the manufacturing label for an immediately preceding manufacturing step, or the plurality of acceptance parameters on the updated manufacturing label for a given time point in the manufacturing process do not meet acceptance criteria for that time point in the manufacturing process (‘896; Paras 0007-0008: a chain of custody of the patient's T cells during the process).
With respect to claim 5, the combined art teaches the method of claim 4, further comprising: performing, at a medical facility, a procedure on the patient to obtain the population of cells from a tumor resected from the patient, transferring the population of cells to the manufacturing facility,after receiving the population of the cells at the manufacturing facility, scheduling, by the computing device, patient treatment events, the scheduling being dependent on the plurality of acceptance parameters for subsequently obtained from the process for manufacturing the cell therapy product, anddetermining the plurality of acceptance parameters for the cell therapy product at a plurality of time points during the process for manufacturing the cell therapy product (‘896; Para 0176).
With respect to claim 6, the combined art teaches the method of claim 4, further comprising providing, by the computing device, a warning signal if: information relating to the patient on the updated manufacturing label for a subsequent manufacturing step does not match the information relating to the patient on the manufacturing label for an immediately preceding manufacturing step, or the plurality of acceptance parameters on the updated manufacturing label for a given time point in the process for manufacturing the cell therapy product do not meet acceptance criteria for that time point in the process (‘242; Para 0107).
With respect to claim 7, the combined art teaches the method of claim 4, further comprising determining a preliminary schedule of manufacturing including a set of dates corresponding to a plurality of time points, including a first time point and a second time point subsequent to the first time point, for determining whether the plurality of acceptance parameters for the manufactured cell therapy product meet acceptance criteria during the process for manufacturing the cell therapy product depending on the cell expansion technique being used and when a cell order request is received at the manufacturing facility (‘896; Paras 0049, 0052).
With respect to claim 8, the combined art teaches the method of claim 7, further comprising receiving courier status information via a logistics computing subsystem, in response to receiving the preliminary schedule, determining shipping schedule for shipping the cell therapy product based on the preliminary schedule of manufacturing; and generating a shipping label for a shipping container containing the cell therapy product (‘896; Paras 0049, 0052).
With respect to claim 9, the combined art teaches the method of claim 8, further comprising transmitting a shipping request to a logistics facility based on the determined shipping schedule (‘896; Para 0010; Para 0052).
With respect to claim 10, the combined art teaches the method of claim 4, further comprising: upon determining that the plurality of acceptance parameters for the cell therapy product met acceptance criteria, determining a completion date for the manufacturing of the cell therapy; generating, by the computing device, a schedule for patient treatment events corresponding to a use of the cell therapy product for treating a patient based on the completion date; transmitting, to a logistics computing subsystem, a pick-up order based on the completion date; and transmitting, to a hospital-side subsystem, the schedule for the patient treatment events (‘896; Para 0040).
With respect to claim 11, the combined art teaches the method of claim 10, wherein the patient treatment events include one or more of an inpatient stay time period, resection date, lymphodepletion date, infusion date for infusing the patient with the cell therapy product and IL-2 treatment date (‘242; Para 0012).
With respect to claim 12, the combined art teaches the method of claim 7, wherein determining whether the plurality of acceptance parameters for the cell therapy product meet acceptance criteria comprises determining the plurality of acceptance parameters for the cell therapy product at a plurality of time points following the initiation of the process for manufacturing the cell therapy product, the plurality of time points including the first and second time points. (‘242; Para 0107)
With respect to claim 13, the combined art teaches the method of claim 4, wherein the cell order request to expand cell therapy product is received from a hospital-side subsystem, and the method further comprises transmitting, upon receiving the cell order request, a confirmation, including one or both of the patient-specific identifier and the cell order identifier, to the hospital-side subsystem that the cell order request associated with the patient has been received (‘896; Para 0130).
With respect to claim 14, the combined art teaches the method of claim 4, further comprising: upon determining that the plurality of acceptance parameters for the cell therapy product do not meet acceptance criteria, determining an updated completion date for the process for manufacturing of the cell therapy; rescheduling the patient treatment events based on the updated completion date; and transmitting, upon rescheduling the patient treatment events, to a hospital-side subsystem an updated schedule for the patient treatment events associated with the patient-specific identifier (‘896; Paras 0139-0140).
With respect to claim 15, the combined art teaches the method of claim 14, further comprising: generating, by the computing device, an updated cell order identifier and an updated schedule for shipping and logistics events associated with the patient treatment events based on the rescheduling of the patient treatment events, and transmitting the updated schedule of shipping and logistics events, the updated cell order identifier, and the associated patient-specific identifier to a logistics subsystem based on the rescheduling of shipping and logistics events (‘896; Para 0049).
With respect to claim 16, the combined art teaches the method of claim 4, further comprising: associating, by the computing device, with the patient-specific identifier at each of the plurality of time points at which a determination of whether the plurality of acceptance parameters meet acceptance criteria is made, an updated cell order identifier including fields corresponding to each respective time point and a result of the determination.
With respect to claim 17, the combined art teaches the method of claim 4, wherein the manufacturing label comprises a graphical identification code encoding the cell order identifier, the patient-specific identifier, and information associated with the patient, the process for manufacturing and quality of the cell therapy product, the graphical identification code being one of a 1-dimensional barcode and a 2- dimensional barcode (896; Para 0133).
With respect to claim 18, the combined art teaches the method of claim 4, further comprising generating a contingent shipping label for a shipping container containing the cell therapy product before performing a final quality control assay, the contingent shipping label being indicative that the cell therapy product is not releasable unless a result of the final quality control assay indicates that the plurality of acceptance parameters meet acceptance criteria (‘896; Para 0137).
With respect to claim 19, the combined art teaches the method of claim 10, further comprising: scheduling, by the computing device, a provision of patient support services based on the schedule for patient treatment events, the provision of patient support services including provision of one or more of support for a patient's travel to and from a medical facility, transmission of requisite health insurance information, transmission of requisite financial reimbursement related information, and provision of treatment events-related services (‘896; Para 0137).
With respect to claim 20, the combined art teaches the method of claim 14, further comprising: scheduling, by the computing device, a provision of patient support services based on the updated schedule for the patient treatment events, the provision of patient support services including provision of one or more of support for a patient's travel to and from a medical facility, transmission of requisite health insurance information, transmission of requisite financial reimbursement related information, and provision of treatment events-related services (‘896; Para 0041: FIGS. 4A to 4D are exemplary screenshots generated by a user interface module to receive confirmation of extraction and infusion sites, and to schedule an appointment, during a patient-specific immunotherapy procedure.; Paras 0049, 0051).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
US-20170051252-A1, Feb. 23, 2017, Morgan, Richard; Improved method for manufacturing adoptive cell therapies.
US-20030235908-A1, Dec. 25, 2003; Berenson Ronald et al; Activation and Expansion of cells.
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/HIEP V NGUYEN/Primary Examiner, Art Unit 3686