DETAILED ACTION
Disposition of Claims
Claims 43-62 were pending. Claims 1-42, 57-58, and 62 are cancelled. Amendments to claims 43-45, 48-49, 55, 59, 61 are acknowledged and entered. New claim 63 is acknowledged and entered. Claims 43-56, 59-61, and 63 will be examined on their merits.
Examiner’s Note
All paragraph numbers (¶) throughout this office action, unless otherwise noted, are from the US PGPub of this application US20230210984A1, Published 07/06/2023. Amendments to the specification presented on 11/26/2025 are acknowledged and entered.
Applicant is encouraged to utilize the new web-based Automated Interview Request (AIR) tool for submitting interview requests; more information can be found at https://www.uspto.gov/patent/laws-and-regulations/interview-practice.
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The Applicant’s representative may wish to consider supplying a written authorization in response to this Office action to correspond with the Examiner via electronic mail (e-mail). This authorization is optional on the part of the Applicant’s representative, but it should be noted that the Examiner may not initiate nor respond to communications via electronic mail unless and until Applicant’s representative authorizes such communications in writing within the official record of the patent application. A sample authorization is available at MPEP § 502.03, part II. If Applicant’s representative chooses to provide this authorization, please ensure to include a valid e-mail address along with said authorization.
Response to Arguments
Applicant's arguments filed 11/26/2025 regarding the previous Office action dated 05/27/2025 have been fully considered. If they have been found to be persuasive, the objection/rejection has been withdrawn below. Likewise, if a rejection/objection has not been recited, said rejection/objection has been withdrawn. If the arguments have not been found to be persuasive, or if there are arguments presented over art that has been utilized in withdrawn rejections but utilized in new rejections, the arguments will be addressed fully with the objection/rejection below.
Specification
(Objection withdrawn.) The objection to the abstract of the disclosure is withdrawn in light of the amendments to the abstract.
(Objection withdrawn.) The objection to the disclosure is withdrawn in light of the amendments to the disclosure.
(Objection withdrawn.) The objection to the disclosure is withdrawn in light of the amendments to the disclosure.
Drawings
(Objection withdrawn.) The objection to the drawings is withdrawn in light of the amendments to the disclosure.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 11/26/2025 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Objections
(Warning withdrawn.) In light of the amendments to the claims, the warning regarding claim 47 and claim 55 is withdrawn.
(Warning withdrawn.) In light of the amendments to the claims, the warning regarding claim 53 and claim 57 is withdrawn.
(Objection withdrawn.) The objection to Claim 62 is withdrawn in light of the cancellation of said claim.
Claim Rejections - 35 USC § 112(b); Second Paragraph
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
(Rejection withdrawn.) The rejection of Claims 45-46 and 59-60 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, is withdrawn in light of the amendments to the claims.
(Rejection withdrawn.) The rejection of Claim 48 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, is withdrawn in light of the amendments to the claim.
(Rejection withdrawn.) The rejection of Claim 49 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, is withdrawn in light of the amendments to the claim.
(Rejection withdrawn.) The rejection of Claims 51, 56, and 60 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, is withdrawn in light of the amendments to the claims.
(Rejection withdrawn.) The rejection of Claim 57 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, is withdrawn in light of the amendments to the claim.
Claim Interpretation
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art.
Claim 43 is drawn to a method of treating or preventing an EBV-associated disease, disorder or condition in a subject, said method including the steps of:
(a) administering to the subject a first population of allogeneic T cells that bind or recognize a first epitope of an EBV antigen;
(b) administering to the subject a second population of allogenic T cells that bind or recognize a second epitope of the EBV antigen or a further EBV antigen; and
(c) administering to the subject an immunotherapeutic agent, a MAPK pathway inhibitor, a BET inhibitor, and any combination thereof; to thereby treat or prevent the EBV-associated disease, disorder or condition in the subject.
Further limitations on the method of Claim 43 are wherein the first population of allogeneic T cells are restricted by a first human leukocyte antigen (HLA) allele, and wherein the cells of the EBV-associated disease, disorder or condition comprise said same HLA allele that encodes a first MHC protein (claim 45), wherein the first MHC protein presents the first epitope of the EBV antigen on cells of the EBV-associated disease, disorder or condition (claim 46), wherein the MHC protein presents the epitope of the EBV antigen on cancer or tumor cells (claim 54); further including the initial step of generating the first population or second population of allogeneic T cells in vitro (claims 47 and 55), wherein the immunotherapeutic agent is or comprises an immune checkpoint inhibitor (claim 48), wherein the immune checkpoint inhibitor is selected from a PD-L1 inhibitor, a CTLA4 inhibitor, a LAG3 inhibitor, a TIM3 inhibitor, or a CD96 inhibitor (claim 63); wherein the MAPK pathway inhibitor is or comprises a MEK1/2 inhibitor (claim 49); wherein the population of allogeneic T cells is administered prior to, simultaneously with and/or subsequent to administration of the therapeutic agent (clam 50); wherein said first epitope of an EBV antigen is an epitope derived from the group of EBV antigens consisting of EBNA1, EBNA2, EBNA3A, EBNA3B, EBNA3C, LMP1, LMP2, and any combination thereof (claim 51); wherein the EBV-associated disease, disorder or condition is or comprises an EBV-associated cancer (claim 52), wherein the EBV-associated cancer is selected from the group consisting of nasopharyngeal carcinoma, NKT cell lymphoma, Hodgkin's Lymphoma, post-transplant lymphoproliferative disease, Burkitt's lymphoma, Diffuse large B-cell lymphoma, gastric cancer, and any combination thereof (claim 53); wherein the second population of allogeneic T cells are restricted by a second HLA allele, and wherein the cells of the EBV-associated disease, disorder or condition comprise said same HLA allele that encodes a second MHC protein (claim 59), wherein the second MHC protein presents the second epitope of the EBV antigen on cells of the EBV-associated disease, disorder or condition (claim 60), and wherein the second population of allogeneic T cells is administered prior to, simultaneously with and/or subsequent to administration of the first population of allogeneic T cells (claim 61).
Claim 44 is drawn to a pharmaceutical composition for treating or preventing an EBV-associated disease, disorder or condition in a subject, the composition comprising:
(a) a first population of allogeneic T cells that bind or recognize a first epitope of an EBV antigen;
(b) administering to the subject a second population of allogenic T cells that bind or recognize a second epitope of the EBV antigen or a further EBV antigen;
(c) a therapeutic agent, wherein the therapeutic agent is selected from the group consisting of an immunotherapeutic agent, a MAPK pathway inhibitor, a BET inhibitor or a combination thereof; and
(d) a pharmaceutically acceptable carrier, diluent, and/or excipient.
Further limitations on the composition of claim 44 are wherein said first epitope of an EBV antigen is an epitope derived from the group of EBV antigens consisting of EBNA1, EBNA2, EBNA3A, EBNA3B, EBNA3C, LMP1, LMP2, and any combination thereof (claim 56).
Claim Rejections - 35 USC § 102
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
(Rejection maintained in part and extended – necessitated by amendment.) Claims 43, 45-47, 50-56, and 59-61 remain rejected under 35 U.S.C. 102(a)(1) as being anticipated by O’Reilly et. al. (US20180125891A1; Pub. 05/10/2018; hereafter “O’Reilly”.) Note the rejection of claims 57-58 is withdrawn in light of the cancellation of said claims.
The Prior Art
O’Reilly teaches methods of treating an EBV-LPD (Epstein-Barr Virus-associated lymphoproliferative disorder) in a human patient who has failed combination chemotherapy to treat the EBV-LPD and/or radiation therapy to treat the EBV-LPD, comprising administering to the human patient a population of allogeneic T cells comprising EBV-specific T cells (entire document; see abstract.) O’Reilly teaches that the allogenic T cells recognize an antigen from EBNA1, EBNA2, EBNA3A, EBNA3B, EBNA3C, LMP1 or LMP2 (reference claim 31; instant claims 51, 56). O’Reilly teaches treatment with the allogenic EBV-specific T cells, then follow-up treatment with chemotherapy or the anti-CD20 monoclonal antibody rituximab (¶[0100-0104]; Table 1; instant claim 50). O’Reilly teaches wherein the allogenic T cells are human leukocyte antigen (HLA) restricted (reference claim 1; instant claim 45) and said allogenic T cells are restricted by the same HLA allele shared with the cells of the EBV-associated disease (EBV-LPD)(¶[0008]; instant claims 45-46, 54). O’Reilly teaches wherein the population of allogenic T cells is generated and expanded in vitro (reference claims 39-56; instant claims 47, 55). O’Reilly teaches that at least one EBV-LPD is an EBV-positive lymphoma, such as EBV-positive B-cell lymphoma or diffuse large B-cell lymphoma (¶[0088]; instant claims 52-53). O’Reilly teaches the methods can include administering to the human patient a second population of allogeneic T cells after said first population of allogenic T cells, wherein said second population is comprising EBV-specific T cells; wherein the second population of allogeneic T cells is restricted by a different HLA allele shared with cells of the EBV-LPD (reference claims 68-69; instant claims 43, 59-61).
For at least these reasons, O’Reilly teaches the limitations of instant claims 43, 45-47, 50-56, and 59-61, and anticipates the invention encompassed by said claims.
Response to Arguments
Applicant's arguments filed 11/26/2025 have been fully considered but they are not persuasive.
Applicant argues that the instant claims are drawn to a method of delivering a pharmaceutical composition comprising two different allogenic T cell populations and a therapeutic agent consisting of an immunotherapeutic agent, a MAPK pathway inhibitor, a BET inhibitor, and any combination thereof, which is completely different from the methods of O’Reilly. Respectfully, the claimed method as presented in instant claim 43 is not drawn to administration of a single composition that comprises these three things, but instead has administration of the following, in no particular order:
A method of treating or preventing an EBV-associated disease, disorder or condition in a subject, said method including the steps of:
(a) administering to the subject a first population of allogeneic T cells that bind or recognize a first epitope of an EBV antigen;
(b) administering to the subject a second population of allogenic T cells that bind or recognize a second epitope of the EBV antigen or a further EBV antigen; and
(c) administering to the subject an immunotherapeutic agent, a MAPK pathway inhibitor, a BET inhibitor, and any combination thereof; to thereby treat or prevent the EBV-associated disease, disorder or condition in the subject. Nowhere in the method of instant claim 43 is a single composition claimed as being administered, nor is it clear that steps a), b), and c) have to be sequential or in any specific order, as the method is broadly claimed as “including the steps of” and does not require said steps to occur in any particular order, just that the steps must occur. One suggestion is to amend claim 43 to require the administration of the pharmaceutical composition of claim 44, as claim 44 clearly provides that the single pharmaceutical composition includes all of the noted elements (and thus is not included in the rejection over O’Reilly.) Additionally, Applicant claims the HLA alleles are drawn to different EBV epitopes. While this is true, the epitopes may be from the same EBV protein, or they may be HLA alleles shared by the patient but for epitopes from different EBV proteins (reference claims 29-31). Again, as the method is claimed more broadly and does not require the compositions to 1) be in a singular composition and 2) delivered in any particular order, it remains that the teachings of O’Reilly anticipate those of the instant claims.
For at least these reasons, the rejection is maintained.
(Rejection withdrawn.) The rejection of Claims 43-47, 49-50, 52, and 54-55 under 35 U.S.C. 102(a)(1) as being anticipated by Rosen et. al. (WO2018106595A1; Pub. 06/14/2018; hereafter “Rosen”) is withdrawn in light of the amendments to the claims.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
(Rejection withdrawn.) The rejection of Claims 44, 48, and 62 under 35 U.S.C. 103 as being unpatentable over O’Reilly as applied to claims 43, 45-47, and 50-61 above, and over Rosen as applied to claims 43-47, 49-50, 52, and 54-55, and further in view of Heslop (ClinicalTrials Study Record ID NCT02973113. Nivolumab With Epstein Barr Virus Specific T Cells (EBVSTS), Relapsed/Refractory EBV Positive Lymphoma (PREVALE) (PREVALE). Heslop, H. Baylor College of Medicine. First Posted: 11/25/2016; hereafter “Heslop”) is withdrawn in light of the amendments to the claims.
(New rejection – necessitated by amendment.) Claims 44, 48-49, and 63 are rejected under 35 U.S.C. 103 as being unpatentable over O’Reilly as applied to claims 43, 45-47, 50-56, and 59-61 above, and further in view of Rosen et. al. (WO2018106595A1; Pub. 06/14/2018; CITED ART OF RECORD; hereafter “Rosen”); and
Galetto et. al. (US20150017136A1, Pub. 01/15/2015; hereafter “Galetto”.)
The Prior Art
The teachings of O’Reilly have been set forth supra. While O’Reilly teaches methods of delivering allogenic EBV-specific T cells to a subject in need thereof in combination with different therapeutic agents, O’Reilly fails to specifically teach the delivery with an immune checkpoint inhibitor (ICI), such as an anti-PD1 antibody, or the delivery of the separate cell populations along with the ICI all in one composition. However, the delivery of multiple cell populations and reagents in a singular composition for adoptive therapy is taught in the art, as evidenced by Rosen, who teaches delivery with other chemotherapeutic agents, such as MEK inhibitors. While Rosen does teach pharmaceutical compositions comprising both the T cells and chemotherapeutic agents, neither Rosen nor O’Reilly teach the chemotherapeutic agent is an ICI, but such a modification would be obvious to a skilled artisan to generate “off-the-shelf” allogenic T cell compositions, given the teachings of Galetto.
Rosen teaches compositions and methods for adoptive cell therapies (entire document; see abstract), including adoptive T cell therapies (¶[0004]), wherein the T cells are targeting EBV-infected cells (¶[0054][00199]). Said EBV-infected cells can be associated with infections, hematological malignancies, solid tumors, or cancers (reference claim 62; instant claim 52). The engineered autologous T cells which target an EBV-infected cell can be present within pharmaceutical compositions, comprising the T cells, a pharmaceutically-acceptable carrier, and an agent to improve the T cell therapy, such as an MEK inhibitors (¶[0010-0011][0017][0033][0054][0126][0134][0143][0158][0201-0212][0217]; Table 1; instant claim 49). Rosen teaches the T cells can match HLA alleles (¶[00111]). Said cells may be generated in vitro (¶[0214]; instant claims 47, 55).
Galetto teaches methods for developing engineered T-cells for immunotherapy that are non-alloreactive, wherein the methods are for modifying T-cells by inactivating both genes encoding T-cell receptor and an immune checkpoint gene to unleash the potential of the immune response, wherein said method utilizes rare cutting endonucleases, namely TALE-nucleases to precisely target a selection of key genes in T-cells (entire document; see abstract.) Galetto teaches that with adoptive T cell therapy that ideally, one would like to use a standardized therapy in which allogeneic therapeutic cells could be pre-manufactured, characterized in detail, and available for immediate administration to patients. By allogeneic it is meant that the cells are obtained from individuals belonging to the same species but are genetically dissimilar. However, the use of allogeneic cells presently has many drawbacks. In immune-competent hosts allogeneic cells are rapidly rejected, a process termed host versus graft rejection (HvG), and this substantially limits the efficacy of the transferred cells. In immune-incompetent hosts, allogeneic cells are able to engraft, but their endogenous TCR specificities recognize the host tissue as foreign, resulting in graft versus host disease (GvHD), which can lead to serious tissue damage and death. In order to effectively use allogeneic cells, both of these problems must be overcome. Galetto teaches that one method in order to not further depress the immune system of the person receiving the adoptive T cell therapy is to engineer the allogenic cells to be non-reactive by targeting immune checkpoints, such as CTLA-4, PD-1, LAG3, TIM3, BTLA, BY55, TIGIT, B7H5, LAIR1, SIGLEC10, and 2B4 (¶[0005-0013]; reference claims 3-7). This overcomes some of these notable issues, and allows for the use of allogenic T cells in patient populations which may be too ill to undergo autologous cell manufacturing. Galetto teaches these immune checkpoints can be targeted with antibodies (¶[0009-0010][0013]) or, more preferably in their system, specific endonucleases (¶[0013-0015]). Galetto teaches their method opens the way to standard and affordable adoptive immunotherapy strategies for treating cancer and viral infections (abstract.)
Given the teachings of O’Reilly and Rosen, one of skill in the art would be apprised as to compositions and methods for treatment of EBV-related cancers and disorders through the use of adoptive T cell therapy. Given the teachings of O’Reilly, one of skill in the art would be apprised as to the methods of generating one or more HLA-matched allogenic T cells against different EBV antigens. Given the teachings of Rosen, a skilled artisan would be apprised as to singular compositions and methods thereof for the adoptive T cell therapy, wherein said composition could comprise additional epitope-targeted T cell populations and adding additional chemotherapeutics to said compositions, such as MEK inhibitors. Given the teachings of Galetto, one of skill in the art would be apprised as to how to make one “off-the-shelf” allogenic T cell therapeutic by utilizing endonucleases that targeted immune checkpoints in the cells to make the chance of GvHD less of an issue and not requiring the use of immunosuppressive agents directly in the host before the use of allogenic T cell compositions. Therefore, arriving at the limitations of instant claims 44, 48-49, and 63 would be obvious to a skilled artisan given the combined and related teachings of O’Reilly, Rosen, and Galetto.
It would have been obvious to one of ordinary skill in the art to modify the methods and compositions taught by O’Reilly in order to utilize inhibitors of immune checkpoints in the compositions, thereby generating compositions with multiple modalities for treatment options. One would have been motivated to do so, given the suggestion by O’Reilly that the method comprising combination treatments provided therapeutic options to the patients with EBV-related cancers that were resistant to traditional treatments. One would have been further motivated to do so, given the teachings by Rosen showing how to make the compositions comprising adoptive T cell therapies more effective through the addition of MEK inhibitors. There would have been a reasonable expectation of success, given the knowledge that methods of engineering the T cell population compositions through the addition of enzymes specific to immune checkpoint inhibitors would be a reasonable method of generating compositions which could be used “off-the-shelf” for any patient and would overcome many of the known issues with traditional allogenic T cell therapeutics, as taught by Galetto, and also given the knowledge that the addition of adoptive EBV-specific T cell therapy appeared to do well in treatment of EBV-related cancers when combined with traditional chemotherapeutic modalities, as taught by O’Reilly. Thus the invention as a whole was clearly prima facie obvious to one of ordinary skill in the art at the time the invention was made.
Response to Arguments
Applicant’s arguments, see “Remarks”, filed 11/26/2025, with respect to the 35 USC 102 rejection over Rosen and the 35 USC 103 rejection over Rosen and O’Reilly in view of Heslop have been fully considered and are persuasive. Therefore, the rejections have been withdrawn. However, upon further consideration, new grounds of rejection are made utilizing the teachings of O’Reilly in view of Rosen and Galetto. The arguments regarding Rosen and O’Reilly with respect to the obviousness rejection will be addressed as applicable herein.
The arguments regarding Rosen not being anticipatory were persuasive, and thus the 35 USC 102 rejection was withdrawn in light of the amendments to the claims. However, the teachings of Rosen were still relevant to the obvious nature of the claims, for the reasons set forth supra. Briefly, Applicant argues that Rosen fails to teach two separate populations of allogenic T cells wherein each population recognizes different sets of EBV epitopes, and Rosen focuses on ex vivo stimulation of the cells. While Rosen teaches a singular population of allogenic T cells which may comprise different populations of T cells which target different epitopes, Rosen never explicitly notes them as being separate EBV epitopes. Further, while Rosen may focus on how to make the populations of antigen-specific T cells, Rosen clearly contemplates the use of said cells in methods of treatment (see e.g. ¶[0013][0036]). O’Reilly teaches generation of different populations of allogenic T cells which recognize different EBV epitopes and delivery of said populations in separate steps, but fails to teach the delivery of both populations in a singular composition. Taken together, it would be obvious to try to determine if both populations could be delivered simultaneously, especially given the further guidance from Galetto as to how to disrupt immune checkpoints and therefore disrupt many known side effects of allogenic adoptive T cell therapy. Therefore, while Rosen may not anticipate the claims as presently amended, Rosen renders obvious the claims in light of the teachings of O’Reilly and Galetto.
With respect to the obvious nature of the claims, the instant rejection utilizes the teachings of O’Reilly and Galetto, and no longer uses the teachings of Heslop. Applicant argued that while Heslop may have shown the use of ICIs in adoptive T cell therapy for EBV, this was for autologous T cell therapy and not allogenic T cell therapy. The teachings of Galetto cure this deficiency, and provide a rationale as to why one would prefer to use allogenic T cell therapy over autologous T cell therapy (e.g. patient in need may be too ill to undergo autologous T cell expansion, need for “off-the-shelf” therapeutic that could be used quickly when needed for a large array of HLA type patient populations). Galetto describes the use of endonucleases to knock out immune checkpoints in cells as opposed to having antibodies present in the cell populations, which would allow for the use of allogenic EBV-specific T cell populations which target multiple antigens yet would be less likely to elicit GvHD in the recipient donor. Therefore, while the original obviousness rejection has been withdrawn, it remains that when taken as a whole, the claim amendments are still drawn to obvious subject matter, as evidenced by O’Reilly, Rosen, and Galetto.
For at least these reasons the arguments were not entirely persuasive, and the claims remain rejected for the reasons set forth supra.
Double Patenting
The text regarding nonstatutory double patenting was presented in a previous Office action.
(Rejection withdrawn.) The provisional rejection of Claims 43-62 on the ground of nonstatutory double patenting as being unpatentable over claims 1-5, 7-16, and 20-22 of copending Application No. 19/038,169 in view of O’Reilly, Rosen, Heslop (supra), and Khanna (Khanna R. “Kissing the Epstein-Barr virus goodbye? https://www.science.org.au/curious/people-medicine/epstein-barr-virus. Australian Academy of Science. Last updated 06/24/2015; hereafter “Khanna”) is withdrawn in light of the amendments to the claims.
(Rejection withdrawn.) The provisional rejection of Claims 43-62 on the ground of nonstatutory double patenting as being unpatentable over claims 1-24 of copending Application No. 18/799,640 in view of O’Reilly, Rosen, Heslop, and Khanna (supra) is withdrawn in light of the abandonment of the ‘003 application.
(Rejection withdrawn.) The provisional rejection of Claims 43-62 on the ground of nonstatutory double patenting as being unpatentable over claims 1, 29, 61, 68-69, 72, 89, and 116-117 of copending Application No. 16/479,003 in view of O’Reilly, Rosen, Heslop, and Khanna (supra) is withdrawn in light of the abandonment of the ‘003 application.
(New rejection – necessitated by amendment.) Claims 43-56, 59-61, and 63 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-5, 7-16, and 20-22 of copending Application No. 19/038,169 in view of O’Reilly, Rosen, Galetto (supra), and Khanna (Khanna R. “Kissing the Epstein-Barr virus goodbye? https://www.science.org.au/curious/people-medicine/epstein-barr-virus. Australian Academy of Science. Last updated 06/24/2015; CITED ART OF RECORD; hereafter “Khanna”.)
Both sets of claims are drawn to methods for treating EBV-related disease using allogenic T cells which have been induced to be specific towards EBV antigens from EBNA-1, LMP1, and/or LMP2a. Both claim the HLA allele is restricted to specific HLA subtypes, both claim the cells have been generated in vitro. The main difference is the instant claims are drawn towards treatment of EBV-positive cancers or proliferative disorders, while the ‘169 claims are drawn towards methods of treating EBV-related autoimmune disorders. However, such differences would be obvious, given the teachings of the prior art as evidenced by O’Reilly, Rosen, and Galetto (detailed supra) and further in view of Khanna. For instance, Rosen teaches the use of these cells to treat autoimmune disorders and viral infections, such as EBV-related infections, rheumatoid arthritis, Sjogren's syndrome, and lupus (¶[0199]). Rosen and O’Reilly teach or suggest the use of EBV-targeting HLA-restricted T cells for treatment of EBV-related infections and/or proliferative disorders, Galetto teaches how to amend said T cell populations through the inclusion of endonucleases to target immune checkpoints to prevent GvHD, and Khanna provides a general audience review of EBV, noting that it causes autoimmune disorders, such as lupus (SLE), Multiple sclerosis (MS), and rheumatoid arthritis (RA), as well as cancers, such as Hodgkin’s lymphoma and Burkitt’s lymphoma (p. 2). Khanna teaches that growing and expanding T-cells in vitro for use in treatment of EBV has been useful in treatment of EBV-related disorders (p. 5, ¶5). Therefore, the use of adoptive T cell therapy as outlined in the instant claims would be an obvious variant of the methods and compositions of adoptive T cell therapy in the ‘169 claims, and the claims are not patentably distinct.
This is a provisional nonstatutory double patenting rejection.
Response to Arguments
Applicant has requested that the non-statutory obviousness-type double patenting rejection be held in abeyance until allowable subject matter is indicated in the present application. However, said rejection must be maintained as a matter of record until the appropriate terminal disclaimers have been filed, or until the claims have been amended in such a way as to not claim patently identical subject matter.
Conclusion
No claims are allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RACHEL B GILL whose telephone number is (571)272-3129. The examiner can normally be reached on M to F 8:00 AM to 5:00 PM Eastern.
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/RACHEL B GILL/
Primary Examiner, Art Unit 1671