DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 07 November 2025 has been entered.
Status of the Claims
The claim set filed 07 November 2025 has been entered into the application.
Claim 135 has been amended.
Claims 1-134 and 141 are previously cancelled.
Claim(s) 135-140 and 142-155 are pending.
Election/Restrictions
Newly submitted claim(s) 155 is directed to an invention that is independent or distinct from the invention originally claimed for the following reasons:
Claim 135 is drawn to an allogenic T-cell delivery system for selecting and delivering an allogenic T-cell line for administration to a patient in need of allogenic T-cell therapy to which incorporates modular system comprising computer modules while new claim 155 is a method for providing a cell therapy.
Additionally, claim 155 encompasses a species:
Species – optionally, receiving a physician assent to treatment of the patient with cell therapy and transporting the first cell line for administration to the patient.
Since applicant has received an action on the merits for the originally presented invention, this invention has been constructively elected by original presentation for prosecution on the merits. Accordingly, claim(s) 155 is withdrawn from consideration as being directed to a non-elected invention and species. See 37 CFR 1.142(b) and MPEP § 821.03.
To preserve a right to petition, the reply to this action must distinctly and specifically point out supposed errors in the restriction requirement. Otherwise, the election shall be treated as a final election without traverse. Traversal must be timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are subsequently added, applicant must indicate which of the subsequently added claims are readable upon the elected invention.
Should applicant traverse on the ground that the inventions are not patentably distinct, applicant should submit evidence or identify such evidence now of record showing the inventions to be obvious variants or clearly admit on the record that this is the case. In either instance, if the examiner finds one of the inventions unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 or pre-AIA 35 U.S.C. 103(a) of the other invention.
The examiner has required restriction between product or apparatus claims and process claims. Where applicant elects claims directed to the product/apparatus, and all product/apparatus claims are subsequently found allowable, withdrawn process claims that include all the limitations of the allowable product/apparatus claims should be considered for rejoinder. All claims directed to a nonelected process invention must include all the limitations of an allowable product/apparatus claim for that process invention to be rejoined.
In the event of rejoinder, the requirement for restriction between the product/apparatus claims and the rejoined process claims will be withdrawn, and the rejoined process claims will be fully examined for patentability in accordance with 37 CFR 1.104. Thus, to be allowable, the rejoined claims must meet all criteria for patentability including the requirements of 35 U.S.C. 101, 102, 103 and 112. Until all claims to the elected product/apparatus are found allowable, an otherwise proper restriction requirement between product/apparatus claims and process claims may be maintained. Withdrawn process claims that are not commensurate in scope with an allowable product/apparatus claim will not be rejoined. See MPEP § 821.04. Additionally, in order for rejoinder to occur, applicant is advised that the process claims should be amended during prosecution to require the limitations of the product/apparatus claims. Failure to do so may result in no rejoinder. Further, note that the prohibition against double patenting rejections of 35 U.S.C. 121 does not apply where the restriction requirement is withdrawn by the examiner before the patent issues. See MPEP § 804.01.
Claims 135-155 are pending. Claim 155 is withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention and species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 23 May 2024.
Claims 135-140 and 142-154 are currently under examination.
Priority
The Applicants claim to priority benefit under 35 U.S.C § 119 to prior-filed Provisional Application No. 62/614,834 is acknowledged.
Specification
The substitute specification(s) received 07 November 2025 have been entered into the application.
The objection to the specification because incorporation by reference in the Office Action mailed 19 May 2025 is withdrawn in view of the amendments received 07 November 2025.
The objection to the specification because new matter in the Office Action mailed 19 May 2025 is withdrawn in view of the amendments received 07 November 2025.
Claim Rejections - 35 USC § 112
35 USC § 112(a)
The rejection of claims 135-140 and 142-154 under 35 U.S.C § 112(a) in the Office Action mailed 19 May 2025 is withdrawn in view of the amendments received 07 November 2025.
35 USC § 112(b)
The rejection of claims 135-140 and 142-154 under 35 U.S.C § 112(b) in the Office Action mailed 19 May 2025 is withdrawn in view of the amendments received 07 November 2025.
The rejection of claims 135-140 and 142-154 under 35 U.S.C § 112(b) in the Office Action mailed 19 May 2025 is withdrawn in view of the amendments received 07 November 2025.
The rejection of claims 135 because product repository under 35 U.S.C § 112(b) in the Office Action mailed 19 May 2025 is withdrawn in view of the amendments received 07 November 2025.
The rejection of claims 135 because “a communication channel”, "an allogenic T-cell match generator", "a registration module" and "a shipping module" under 35 U.S.C § 112(b) in the Office Action mailed 19 May 2025 is withdrawn in view of the amendments received 07 November 2025.
The rejection of claims 135 because “a communication channel” under 35 U.S.C § 112(b) in the Office Action mailed 19 May 2025 is withdrawn in view of the amendments received 07 November 2025.
The rejection of claims 136-140 and 142-154 under 35 U.S.C § 112(b) in the Office Action mailed 19 May 2025 is withdrawn in view of the amendments received 07 November 2025.
Claim Rejections - 35 USC § 101
The rejection of claims 135-140 and 142-154 Office Action mailed 19 May 2025 is withdrawn in view of the amendments filed 07 November 2025.
Claim Rejections - 35 USC § 103
It is noted the amendments received 07 November 2025 necessitated new ground(s) of rejection.
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 135-140, 142, 144-146, 151, and 153 are rejected under 35 U.S.C. 103 as being unpatentable over Klein et al. (U.S Patent Pub: US 2013/0041680; Patent Pub Date: 14 February 2013; Cited in the Office Action mailed 24 January 2024) in view of Khanna et al. (International Patent Pub No: WO 2017/203368; Patent Pub Date: 30 November 2017) in view of Kruse et al. (Patent Pub: US 2011/0027245; Patent Pub Date: 03 February 2011; Cited in the Office Action mailed 24 January 2024).
Claim 135 recites a product repository, the product repository comprising a plurality of samples comprising antigen-specific Cytotoxic T-Lymphocytes (CTLs), the CTLs of each sample having a known Human Leukocyte Antigen (HLA) profile and a known HLA restriction for the target antigen, and exhibiting allo-reactivity below a predetermined threshold.
Claim 135 recites a communication channel having an interface between a health care provider and a T-cell therapy provider, the communication channel receiving patient-characteristic data, including patient identification information and the HLA profile of the patient's somatic or diseased cells and, optionally, a physician assent to treatment of the patient with the allogeneic T-cell therapy.
Claim 135 recites an allogeneic T-cell match generator, wherein the allogeneic T-cell match generator comprises an allogeneic T-cell match generator algorithm for determining an ordered set of cell lines from the product repository, the ordered set of cell lines prioritized at least according to a pre-determined match level between the HLA profile of the patient's somatic or diseased cells and HLA profiles and known restriction(s) of cell lines in the product repository, the ordered set of cell lines comprising a first cell line having a highest priority of the cell lines.
Claim 135 recites a registration module, for receiving and registering the first cell line for administering to the patient.
Claim 135 recites a shipping module or coordinating transport of the first cell line for administration to the patient.
Claim 135 recites wherein the computer system comprises a central processing unit; and a memory, coupled to the central processing unit, the memory storing computer- executable instructions for determining by the allogenic T-cell match generator, registering by the registration module, and coordinating transport by the shipping module.
Klein et al. (Klein) discloses a plurality of allogeneic cell preparations stored in a plurality of cell banks [disclosure, page 6 left col para 0056-0061], as in claim 135 a product repository.
Klein discloses a network of computers by which the system functions are implemented [page 3 left col 0019-0023]. Klein discloses the system coordinates a transplantation of stem cells, for example, between clinics and the UCB banks in the shortest amount of time [page 12 right col 0178]. Klein discloses “when the order is placed by the physician, the system automatically ensures that the preparations which are part of a proposed and selected solution are ordered from the various UCB banks.” [page 12 left col para 0178]. Klein discloses “Coordination between clinic, diagnostics and logistics service providers, processers, transplant center, and attending physician is preferably carried out by means of the preferred embodiment. This ensures reliable communication between the clinic, i.e., optionally the attending physician, and the transplant center, as well as any other involved parties.” [page 11 right col para 0172]. Klein discloses a communication channel between clinics, transplant center, and research facility [Klein, claim 1]. Klein discloses HLA matches and other patient data [Klein claims 1-5], as in instant claim 135 a communication channel having an interface between a health care provider and a T-cell therapy provider, the communication channel receiving patient-characteristic data, including patient identification information and the HLA profile of the patient's somatic or diseased cells and, optionally, a physician assent to treatment of the patient with the allogeneic T-cell therapy.
Dependent claims 140, 146, and 153.
Klein discloses a source of hematopoietic stem cells [page 3 right col para 0222–0223] which are a type of peripheral blood mononuclear cells, as in claim 140.
Klein discloses "the workflow management offers the option for … assisting in appropriate follow-up processes in which, for example, appropriate information is asked of the users at certain points in time." [page 16 left col para 0224], as in claim 146.
Klein discloses “Order processing and tracking, including integration of service providers comprising diagnostics service providers, logistics service providers, and/or processers, wherein the system carries out financial transactions, and in particular, the potential umbilical cord blood preparations being arranged and selected according to priority of a bank, medical and logistical factors including time and cost projections, probability of therapeutic success, HLA match, patient weight, number of nucleated cells (TNC), number of hematopoietic cells (CD34+), and number of CD133+ cells and/or other comparable cells.” [Klein claim 1], as in claim 153. Here, it would be obvious to sort the product repositories based on donor, bank, HLA match, and other comparable cells, for example.
With respect to claim 135 wherein the computer system comprises a central processing unit; and a memory, coupled to the central processing unit, the memory storing computer- executable instructions for determining by the allogenic T-cell match generator, registering by the registration module, and coordinating transport by the shipping module, it is obvious that the computer system of claim 135 would encompass central processing unit and a memory, coupled to the central processing unit, the memory storing computer-executable instructions for executing the computer modules/algorithm (i.e., allogenic T-cell match generator, registration module, and the shipping module).
Klein does not teach claim 135 the product repository comprising a plurality of samples comprising antigen-specific Cytotoxic T-Lymphocytes (CTLs), the CTLs of each sample having a known Human Leukocyte Antigen (HLA) profile and a known HLA restriction for the target antigen, and exhibiting allo-reactivity below a predetermined threshold.
Klein does not teach claim 135 an allogeneic T-cell match generator, wherein the allogeneic T-cell match generator comprises an allogeneic T-cell match generator algorithm for determining an ordered set of cell lines from the product repository, the ordered set of cell lines prioritized at least according to a pre-determined match level between the HLA profile of the patient's somatic or diseased cells and HLA profiles and known restriction(s) of cell lines in the product repository, the ordered set of cell lines comprising a first cell line having a highest priority of the cell lines.
Klein does not teach claim 135 a registration module, for receiving and registering the first cell line for administering to the patient. Klein does not teach claim 135 a shipping module or coordinating transport of the first cell line for administration to the patient. Klein does not teach claim 145.
Khanna et al. (Khanna) discloses using an algorithm (i.e., T-cell match generator algorithm) for selecting CTL’s from a third party donor cell line derived from a bank of CTL epitopes [page 17 lines 18-19]. Khanna discloses the algorithm Khanna discloses using an algorithm for patient-specific requisitioning of banked products that are ordered and prioritized (hierarchical considerations) with patient (i.e., subject’s) genetics or disease background. Khanna discloses the algorithm can be based on HLA restriction or HLA matching using multiple lots in conjunction with appropriately weighted and including additional lot and/or patient-specific characteristic and annotations to select the most effective patient-specific lot, or one that most mitigate potential for adverse events [page 17 lines 25-29]. Khanna discloses a process that describes selecting allogenic third-party Epstein Barr Virus (EBV)-CTL’s for a subject (i.e., patient) using a requestioning algorithm (i.e., T-cell match generator algorithm). In general, the algorithm encompasses the following process: 1) matches cells lines with patients based if they share greater than or equal to 2 HLA loci and matched to the given CTL line’s HLA restriction (i.e., the ordered set of cell lines prioritized at least according to a pre-determined match level between the HLA profile of the patient's somatic or diseased cells and HLA profiles), 2) dosing requirement, 3) using identified cell lines and repeating previous step 1) and 2) for multiple cell lines meeting dosing and HLA matching requirements, and 3a)-3d) describes steps for selecting cell lines for cells previous and not previously administered [page 18 lines 19-32, page 19 lines 1-5]. Khanna discloses a method for treating and or preventing an autoimmune disease in a subject by a) incubating antigen-presenting cells (APC’s), b) inducing peptide-specific CTL proliferation by incubating a sample comprising allogeneic CTLs with the antigen-presenting cells (APCs), c) administering the peptide-specific allogeneic CTLs to the subject [Khanna, claim 12]. Here, Khanna teaches steps that construct an HLA profile based on allogenic CTL’s responses with respect to treating a somatic mutation or disease such as an autoimmune disease. Khanna discloses “3c) If there are no cell lines with a previous response rate, select among cell lines whose HLA restriction has been shown previously to elicit responses, prioritizing which cell line by the HLA restriction shared with the subject (or subject's disease) with the highest previous response.” (i.e., the ordered set of cell lines comprising a first cell line having a highest priority of the cell lines.) [page 19 lines 1-2]. Therefore, Khanna discloses an allogeneic T-cell match generator, wherein the allogeneic T-cell match generator comprises an allogeneic T-cell match generator algorithm for determining an ordered set of cell lines from the product repository, the ordered set of cell lines prioritized at least according to a pre-determined match level between the HLA profile of the patient's somatic or diseased cells and HLA profiles and known restriction(s) of cell lines in the product repository, the ordered set of cell lines comprising a first cell line having a highest priority of the cell lines of claim 135.
Kruse et al. (Kruse) discloses collecting alloCTL preparations from a plurality of donors [page 2 right col para 031–0033]. Kruse discloses each preparation having a unique profile of HLA antigens [page 2 right col para 0036–0042; specific example in 0214, Table 2]. Kruse discloses using tumor bank/HLA-typed tumors and using seventeen cultured glioma cell explants and established glioma cell lines [disclosure page 22 right col para 0215; page 23 table 3]. Here, the tumor bank and alloCTL preparation having unique profile to HLA antigens of Kruse discloses a product repository comprising a plurality of samples comprising antigen-specific Cytotoxic T-Lymphocytes (CTLs), the CTLs of each sample having a known Human Leukocyte Antigen (HLA) profile. Kruse discloses “the CD3+/CD8+ cells react by producing proinflammatory IFN-y upon exposure to the relevant HLA glioma antigens.” [disclosure page 23 left col para 0218]. Kruse discloses using mean fluorescence intensities (MFI) for measuring alloCTL responses with glioma cell before and after exposure to target glioma [page 24 table 5]. Kruse discloses the alloCTL were analyzed for CD3+/CD4+/C69+ cells with the relevant target percentage of 2.3-fold but less than 1% of them were IFN-γ positive with the CD3+/CD8+ cells reacting by producing proinflammatory IFN-y upon exposure to the relevant HLA glioma antigens [disclosure, page 23 para 0218]. Here, Kruse discloses analyzing the response of alloCTL against glioma cell/tumor using techniques such as MFI for measuring IFN-γ production with respect to alloCTL’s (i.e., CD3+/CD8+ cells) producing proinflammatory IFN-y upon exposure to the relevant HLA glioma antigens [page 23 right col para 0218] which suggests that alloCTL’s exhibit allo-reactivity (i.e., IFN-γ production) below a predetermined threshold when exposed to HLA glioma antigens. Khanna discloses selecting allogenic CTL’s from a cell bank that express TCR restricted to a class I MHC that is encoded by an HLA allele [page 16 lines 7-10]. Therefore, it would be obvious that combining the tumor bank and alloCTL preparation having unique profile to HLA antigens and response analysis of alloCTL against glioma cell/tumor of Kruse with selecting allogeneic CTL’s that are restricted to class I MHC molecules of Khanna from a bank [page 17 lines 20-29] would yield a product repository comprising a plurality of samples comprising antigen-specific Cytotoxic T-Lymphocytes (CTLs), the CTLs of each sample having a known Human Leukocyte Antigen (HLA) profile and a known HLA restriction for the target antigen, and exhibiting allo-reactivity below a predetermined threshold.
With respect to claim 135 a registration module, for receiving and registering the first cell line for administering to the patient, Klein discloses "providing the attending physician with the opportunity to initiate an order, delivery, and possible further processing of one or more preparations as soon as the system recognizes, based on comparing the inventory of preparations to the patient register, one or more solutions for the treatment of an individual patient." [page 5 right col para 0051]. Klein discloses “for selection kits by leading manufacturers, which make selection and concentration of important stem cells possible, in particular CD133+ from basic material such as bone marrow or also umbilical cord blood, in sufficient quantities for the causal therapy in DCM when administered using the NOGA system.” [page 12 left col para 0177]. Kruse discloses administering doses alloreactive T-cell [Kruse, claims 21-22 and 25]. Therefore, the registration module for receiving and registering first cell lines for administering is rendered obvious.
With respect to claim 135 a shipping module or coordinating transport of the first cell line for administration to the patient, Klein discloses preparing the allogeneic cell preparation for shipment [page 9 right col para 0127] and tracking shipment logistics [page 10 right col para 0158]. Klein discloses “for selection kits by leading manufacturers, which make selection and concentration of important stem cells possible, in particular CD133+ from basic material such as bone marrow or also umbilical cord blood, in sufficient quantities for the causal therapy in DCM when administered using the NOGA system.” [page 12 left col para 0177]. Kruse discloses administering doses alloreactive T-cell [Kruse, claims 21-22 and 25]. Therefore, the shipping module for coordinating cell line transport is rendered obvious.
Dependent claim 144
Kruse discloses a composition may be administered in intervals such that the composition maybe administered 1 to 20 times at intervals 1 month to about 6 months, 1 day to 60 days, or about 1 to 7 days [disclosure, page 19 left col para 0180], as in instant claim 144. Thus, it is obvious that a first cell line can shipped to the ordering physician for administration within 7 days of physician assent.
Obvious claims:
136-139, 142, 145, and 151
Khanna discloses storing allogenic CTL’s (i.e., set of cell lines) of a subject in a cell bank for administering [Khanna, claim 12]. Klein discloses e system that compares the patient data of the administered patient registers with the data of registered cell preparations, using a multi-level compatibility matrix and varying classification criteria [Klein disclosure para 0028], as in instant claim 136. Thus, Khanna and Klein disclose a claimed step that stores cell lines associated with patient data.
Klein discloses a transplantation center system architecture that illustrate computer interactions and communication between transplant center, patients, and physicians [figure 3]. Klein discloses the attending physician registers the patient in question in the system, indicating the necessary data such as, for example, HLA type, weight, or further molecular diagnostic data [0052]. Klein discloses once the transplant clinic or the attending physician has selected one or more UCB preparations, the preparation can be ordered from the UCB bank and be reserved for a patient or a clinic [Klein, disclosure para 0220], as in instant claim 137. Here, the system of Klein makes obvious using a registration module that can receive and register physician assent because Klein discloses registering a patient into a computer system using patient data such as weight, HLA type, gender, patient insurance number [Klein, claims 1-5].
Klein discloses that a physician can determine HLA values of patients and pass them on together to the TC coordinator for searching of UCB preparations (i.e., cell lines) [page 15 left col para 0221]. Klein discloses the system allows a physician to recognize specific treatment corridors or exclusion criteria of approved therapies and to inform patient of the same prior to treatment [page 16 left col 0225], as in instant claim 138. Here, it is obvious that physician assent (i.e., prescription or other physician-initiated requests [Spec page 2 last para]) is received before HLA patient information because it is known in the art that a physician has to first prescribed or place an order for laboratory work-ups, drugs, or preparations such that an institution or center (i.e., TC) can begin to concoct a patient’s HLA profile/information.
Klein discloses once the transplant clinic or the attending physician has selected one or more UCB preparations, the preparation can be ordered from the UCB bank and be reserved for a patient or a clinic. Klein discloses that after selection of the preparation the preparation maybe ordered or delivered [Klein, disclosure para 0220], as in claim 139. Thus, it would be obvious that the prepared cell line is communicated with the patient’s physician prior to approved because Klein discloses the physician selects a USB preparation and the preparation can, then, be ordered and/or shipped. Therefore, the UCB preparation (i.e., cell lines for transplant) are communicated to the physician before ordering and shipping.
Klein discloses a clinic in need UCB preparation for patients would inquire the registers as to whether they have a UCB preparation available for the patient [page 1 left col para 0002], as in instant claim 142. Here, it is obvious the system confirms the available of a UCB preparation (i.e., cell line) before shipping because it is known in the art that a distribution center (i.e., repository) would confirm availability of a product before shipping.
Kruse discloses “Multiple doses can be delivered over time to achieve a desired effect, and often, each dose delivers an effective amount of cells. Cells in the composition delivered can contain a mixture of responder cells and stimulator cells” [page 18 right col para 0178]. Kruse discloses steps for administering alloreactive T-cell to patient the patient [Kruse, claims 21-22 and 25]. Khanna discloses a method for treating and preventing an autoimmune disease and administering peptide specific allogenic T-cells [Khanna, claim 11]. Khanna discloses ascertaining adequate cell dose [page 18 lines 5-9 2)], as in claim 145.
Klein discloses a clinic in need UCB preparation for patients would inquire the registers as to whether they have a UCB preparation available for the patient [page 1 left col para 0002], as in instant claim 151. Here, it is obvious the system confirms the available of a second UCB preparation (i.e., second cell line) before shipping because it is known in the art that a distribution center (i.e., repository) would confirm availability of a product before shipping.
It would have been obvious to one or ordinary skill by the effective filing date of the claimed invention to modify Klein in view of Khanna because Khanna discloses methods for using allogenic cytotoxic T cells expressing a T-cell receptor that binds to an EBV virus peptide presented on class I MHC molecule [abstract]. One of ordinary skill in the art would be motivated to combine Kruse in view of Khanna because Khanna discloses a requestioning algorithm (i.e., T-cell match generator algorithm) that orders and provides hierarchal consideration (i.e., prioritization) for ordering and matching cell lines [page 17 lines 20-29]. Here, one of ordinary skill in the would recognize the algorithm of Khanna could be incorporated into the modular system of Klein [figures 3-4] in order to construct a computer-implemented method for selecting allogenic and/or alloreactive immune cells (i.e., CTL’s). Therefore, combining/incorporating the requestioning/selection algorithm of Khanna into the modular system of Klein would yield a predictable T-cell therapy delivery system for selecting, ordering, prioritizing, and administering the most effective patient lot (i.e., allogenic T-cell line(s)).
It would have been obvious to one or ordinary skill by the effective filing date of the claimed invention to modify Klein in view of Khanna in view of Kruse because Kruse discloses using cytotoxic T-lymphocytes (CTL’s) having known human leukocyte antigen (HLA) and known restriction for target antigen [page 30 right col para 0285] and using allo-reactivity thresholds [page 23 left col para 0218]. One of ordinary skill in the art would recognize that Klein discloses a system and Khanna discloses a matching, ordering, and prioritizing cell lines algorithm that can be utilized for processing and shipping the cells of Kruse.. Thus, and prior to the time of invention, said practitioner would have been motivated to use the allogeneic cell management system of Klein and the matching, ordering, and prioritizing cell line algorithm of Khanna to manage the allogeneic CTL preparations of Kruse, because Klein teaches that the system has numerous advantages for ensuring that the correct recipient receives the correct cell preparation quickly and efficiently, thereby improving the allogeneic CTL preparation method of Kruse. Given that Klein teaches that the system can be used to manage any kind of allogeneic cell preparation and Khanna discloses methods for ordering and hierarchal consideration (i.e., prioritizing) of cell lines, said practitioner would have readily predicted that the combination would successfully result in a system for managing allogeneic CTL preparations. Therefore, combining the Klein in view of Khanna in view of Kruse would yield predictable computer-implemented allogeneic T-cell therapy delivery system that uses a computer system configured for selecting an allogeneic T-cell line for administration to a patient in need of allogeneic T-cell therapy.
Claim 154 is rejected under 35 U.S.C. 103 as being unpatentable over Klein in view of Khanna in view of Kruse, as applied to claims 135-140, 142, 144-146, 151, and 153, and in further view of O’Reilly et al. (U.S Patent Pub: US 2017/0319683; Patent Pub Date: 19 November 2017; Cited in the Office Action mailed 21 September 2023).
Klein in view of Khanna in view of Kruse teach claims 135-140, 142, 144-146, 151, and 153.
Klein in view of Khanna in view of Kruse disclose a computer-implemented allogeneic T-cell delivery system that uses computer memory and processing units for selecting allogenic T-cell line for administration to a patient using a CTL repository, communication channel, an allogenic T-match generator algorithm, and registration and shipping modules.
Klein in view of Khanna in view of Kruse does not teach claim 154.
O’Reilly et al. (O’Reilly) discloses EBV-positive post-transplant lymphoproliferative disorder [disclosure, page 11 left col para 0125]. O’Reilly discloses EBV-positive post-transplant lymphoproliferative disorder [O’Reilly, claim 29].
It would have been obvious to one of ordinary skill in the art by the effective filing date of the claimed invention to modify Klein in view of Khanna in view of Kruse, and in further view of O’Reilly because O’Reilly discloses using allogenic T-cells for treating EBV-positive post-transplant lymphoproliferative disorder [O’Reilly, claim 1 and 29]. One of ordinary skill in the art would be motivated to combine Klein in view of Khanna in view of Kruse, and in further view of O’Reilly because O’Reilly discloses methods of selecting an allogeneic T cell line for therapeutic administration to a patient having or suspected of having a pathogen or cancer [abstract] or having EBV-positive post-transplant lymphoproliferative disorder [Klein, claims 1 and 29]. Thus, combining the cell processing and shipping system of Klein in view of the requestioning algorithm of Khanna in view of the allogenic repository of Kruse in further view of using allogeneic T-cells to treat EBV-positive post-transplant lymphoproliferative disorders of O’Reilly would yield a predictable computer-implemented method that can be used by a medical provider for ordering and selecting allogeneic T-cell lines for administering to patients with post-transplant lymphoproliferative disorders.
Conclusion
Claims 135-140 and 142-154 are rejected.
No claims are allowed.
Finality
This Office action is a Non-Final action. A shortened statutory period for reply to this action is set to expire THREE MONTHS from the mailing date of this action.
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/J.C.P./ Examiner, Art Unit 1687
/Anna Skibinsky/
Primary Examiner, AU 1635