DETAILED ACTION
Disposition of Claims
Claims 1-2, 7, 9, 14-15, 17-18, 20-21, 23, 28, 33, 38, 43, 47, 93-95, and 99 remain pending. Claims 3-6, 8, 10-13, 16, 19, 22, 24-27, 29-32, 34-37, 39-42, 44-46, 48-92, and 96-98 remain cancelled. No amendments have been entered. Claims 1-2, 7, 9, 14-15, 17-18, 20-21, 23, 28, 33, 38, 43, 47, 93-95, and 99 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 US20210393684A1, Published 12/23/2021. Amendments to the specification presented on 06/13/2024 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.
Response to Arguments
Applicant's arguments filed 04/28/2026 regarding the previous Office action dated 10/28/2025 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 If they have been found to be persuasive, the objection/rejection has been withdrawn below. Likewise, if a rejection/objection has not been recited, said rejection/objection has been withdrawn.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arguments have not been found to be persuasive, or if there are arguments presented over art that has been utilized in withdrawn rejections but utilized in new rejections, the arguments will be addressed fully with the objection/rejection below.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 04/28/2026 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Interpretation
The scope of the claims was presented in a previous Office action, and since no amendments to the claims have been presented, the claim scope interpretation will not be repeated herein.
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.) Claim 2 remains rejected under 35 U.S.C. 102(a)(1) as being anticipated by Khanna-2005 et. al. (US20050019344A1; Pub. 04/28/2009; hereafter “Khanna-2005”.)
The rationale behind this rejection was presented in a previous Office action and will not be repeated herein.
Response to Arguments
Applicant's arguments filed 04/28/2026 have been fully considered but they are not persuasive.
Applicant argues that Khanna-2005 fails to teach a pool of HLA Class I and II immunogenic peptides, wherein the peptide pool comprises at least one peptide epitope derived from each of the CMV antigens pp50, pp65, IE-1, gB, and gH and an adjuvant. This argument is not persuasive.
Khanna teaches the identification of HCMV CTL epitopes from multiple HCMV antigens and expressly states that the HCMV-specific CTL response is not limited to pp65, IE-1, or pp150. Khanna further teaches that clonal analysis revealed individual responses to antigens, including HCMV antigens pp28, pp50, pp65, pp150, gB, gH, US2, IE-1, and IE-2 (¶[0127][0339][0361]), and teaches that an effective CTL epitope-based HCMV vaccine should comprise epitopes derived not only from pp65 and IE-1, but also from other HCMV genomic regions expressed during early, late, and latent infection (¶[0073]).
Khanna also teaches vaccine compositions for eliciting a cellular immune response against HCMV comprising one or more immunologically active peptides (¶[0256]), which reasonably reads upon a “pool” of “immunogenic peptides”. Said composition of immunologically active peptides can include single epitopes or polyepitopes, in combination with a pharmaceutically-acceptable carrier, excipient, diluent, and/or adjuvant (¶[0256]). Therefore, Khanna is not limited to isolated single-peptide embodiments, and expressly contemplates multi-epitope HCMV vaccine compositions with adjuvant.
Applicant’s argument that Khanna does not use the word “pool” is unpersuasive. The claim does not define “pool” in a manner requiring a particular structure beyond a combination/plurality of immunogenic peptides, nor does the application appear to redefine or limit this term structurally. Khanna teaches compositions comprising more than one immunologically active HCMV peptide/epitope or polyepitope. Such a multi-peptide composition under broadest reasonable interpretation reads on the claimed peptide “pool”.
Applicant’s argument regarding the mixture of HLA class I and II epitopes is also unpersuasive. Khanna teaches HLA Class I-restricted CTL epitopes across numerous HLA alleles and further teaches that preferred polyepitopes may comprise one or more CD4+ determinants sufficient to facilitate helper T cell function in the context of an MHC class II molecule (¶[0076]). Khanna further explains that, when using 20-mer peptides, some responses may be MHC class II-restricted rather than class I-restricted (¶[0380]), and identifies MHC class II-restricted epitopes within HCMV antigen derived 20-mer sequences, including gH (Fig. 10, ¶[0380-0382]). Accordingly, Khanna teaches both HLA class I-restricted CMV peptide epitopes and MHC class II/CD4+ T helper determinants in the context of HCMV peptide vaccine design.
To the extend that Applicant argues that Khanna does not provide an example physically combining one peptide from each of pp50, pp65, IE-1, gB, and gH in a single named formulation, the argument is not commensurate in scope with the claim language. Claim 2 is broadly drawn to a pool comprising at least one epitope derived from each of the CMV antigens comprising pp50, pp65, IE-1, gB, and gH and an adjuvant. The claim does not require a specific peptide sequence from any of the listed antigens, does not require any particular HLA allele restriction, does not require any specific class I/class I ratio, and does not require experimental demonstration of the exact pool. Khanna’s disclosure of multi-epitope HCMV vaccine compositions, including epitopes/polyepitopes derived from the recited antigens and formulated with an adjuvant, meets the broadly recited claim.
Applicant argues that Khanna only teaches polyepitope constructs, rather than multiple single isolated peptides. This argument is not persuasive. As noted supra, Khanna clearly teaches one or more peptides in a single composition, and does not limit their disclosure to only polyepitope constructs. See also ¶[0256], abstract. As noted infra, Applicant’s own specification (¶[0036]) is drawn to full-length CMV proteins and polyepitope constructs reading on “peptides”. There is no structural limitation within the claim language that limits the size or type of peptide within the claimed composition.
Applicant further argues that Khanna fails to teach the specific combination of only pp50, pp65, IE-1, gB, and gH. This argument is not persuasive. Claim 2 does not utilize close-ended transitional phrases (e.g. “consists essentially of” or “consists of”) but instead uses open-ended transitional phrases which allow for the presence of additional, unrecited elements in the composition. Khanna teaches HCMV-specific T cell responses and vaccine compositions involving multiple HCMV antigens, including the presently recited antigens pp50, pp65, IE-1, gB, and gH. Khanna further teaches that an effective CTL epitope-based HCMV vaccine should include epitopes beyond pp65 and IE-1, and should include epitopes derived from other HCMV proteins. Read as a whole, Khanna directs the skilled artisan to include epitopes from multiple CMV antigens, rather than limiting the vaccine composition to a single antigen or a single polyepitope construct.
Applicant’s argument improperly requires Khanna to disclose the claimed arrangement using the same wording as the claim or in a separately claimed example. Such a showing is not required as per MPEP§2131.02.II-III, which clearly states that a reference that clearly names the claimed species anticipates the claim no matter how many other species are named, and that a generic disclosure will anticipate a claimed species covered by that disclosure when the species can be “at once envisaged” from the disclosure. This section of the MPEP clearly states that when the reference disclosure provides a limited and well-delineated set of possibilities from which the claimed subject matter would be immediately envisaged, that said reference disclosure is an anticipatory teaching. In the instant case, Khanna does not disclose an amorphous, unrelated list of possibilities. Khanna teaches HCMV peptide vaccine compositions comprising one or more immunologically active peptides, expressly including single epitopes, polyepitopes, or more than one epitope/polyepitope, in combination with an adjuvant, and identifies a specific subset of HCMV antigens. Therefore, a skilled artisan could reasonably “at once envisage” a composition which comprises the HCMV antigens pp50, pp65, IE-1, gB, and gH.
For at least these reasons, Applicant’s arguments are not persuasive, and the rejection is maintained.
(Rejection maintained.) Claim 2 remains rejected under 35 U.S.C. 102(a)(1) as being anticipated by Sampson et. al. (US20160213771A1; Pub. 07/28/2016; hereafter “Sampson”) as evidenced by Khanna-2005 et. al. (US20050019344A1; Pub. 04/28/2009; hereafter “Khanna-2005”.)
The rationale behind this rejection was presented in a previous Office action and will not be repeated herein.
Response to Arguments
Applicant's arguments filed 04/28/2026 have been fully considered but they are not persuasive.
First, Applicant argues that Sampson fails to teach the peptide pools. Contrary to Applicant’s assertion, Sampson expressly teaches that “the at least one antigen corresponds to a pool of peptides” and further teaches that the pool of peptides may comprise overlapping peptide sequences covering at least about 10% to 100% of an HCMV protein (¶[0097]), and that peptide pools of CMV antigens that stimulate T cells were known in the art (¶[0103]). Sampson also teaches immunogenic compositions comprising the pool of peptides (¶[0099-0100]), and states that the peptide(s), including the pool of peptides, may be administered as a peptide or lipopeptide vaccine, optionally with an adjuvant (¶[0102]).
Second, Applicant argues that Sampson fails to teach the peptide pools of discrete peptides derived from each of the five recited CMV antigens. As set forth supra, claim 2 utilizes open-ended transitional phrasing which allows for the addition of unrecited elements, so compositions may comprise additional CMV antigens beyond gB, IE-1, pp65, pp50, and gH. The claim does not structurally limit the composition to only peptides from only these CMV antigens, nor does the claim provide a specific size limitation with respect to the peptides. Guidance from Applicant’s own specification at ¶[0036] notes that:
“In some embodiments, the peptides provided herein are full length CMV polypeptides. In some embodiments, the peptides provided herein comprise less than 100, 90, 80, 70, 60, 50, 40, 30, 25, 20, 15 or 10 contiguous amino acids of the CMV viral polypeptide. In some embodiments, the peptides provided herein comprise two or more of the CMV epitopes listed in Table 1. For example, in some embodiments, the peptides provided herein comprise two or more of the CMV epitopes listed in table 1 connected by polypeptide linkers. In some embodiments, the peptide provided herein comprises at least 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19 or all of the epitopes listed in Table 1.”
By Applicant’s own specification, a “peptide” can reasonably comprise the entire full-length CMV protein. Additionally, the peptide may also be present as a polyepitope polyprotein. Regardless, Sampson teaches that full-length CMV proteins (¶[0300][0302][0308]) or shorter peptides thereof (¶[0097]) which are immunologically active (¶[0101]) can be used in the immunogenic compositions with an adjuvant.
Third, Applicant argues that Sampson fails to teach a mix of HLA class I and class II antigens in the pool. This argument is unpersuasive in that Sampson teaches that the one or more epitopes may be restricted to HLA/MHC Class I molecules, and also further teaches that the immunologically active peptide may additionally comprise one or more CD4+ determinants sufficient to facilitate a T-helper function in the context of an MHC class II molecule on the surface of an antigen presenting cell (APC). In one embodiment, Sampson teaches that peptides comprising contiguous or overlapping CTL epitopes and T-helper epitope functions are provided that are capable of binding to both CD4+ and CD8+ cells (¶[0094]). Therefore, Sampson teaches a peptide-based CMV immunogen that includes both class I CTL epitope functionality and class II/CD4+ T-helper determinant functionality.
With Sampson teaching that the at least one CMV antigen may comprise one or more epitopes from the same antigen or from distinct antigens of CMV, and with Sampson incorporating the teachings of Khanna (supra) as evidence of CMV epitopes which are known in the art (including pp50, pp65, IE-1, gB, and gH), and with Sampson teaching that full-length CMV proteins (¶[0300][0302][0308]) or shorter peptides thereof (¶[0097]) which are immunologically active (¶[0101]) and can be in a vaccine composition with an adjuvant (¶[0102]), and with Sampson teaching that class I and II MHC epitopes may be used, Sampson (as evidenced by Khanna) clearly anticipates the limitations of instant claim 2.
For at least these reasons, Applicant’s arguments are not persuasive, and the rejection is maintained.
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 maintained.) Claims 1, 7, 9, 14-15, 17-18, 20-21, 23, 33 remain rejected under 35 U.S.C. 103 as being unpatentable over Sampson and Khanna-2005 as applied to claim 2 above, and further in view of Sylwester et. al. (Sylwester AW, et. al. J Exp Med. 2005 Sep 5;202(5):673-85.; CITED ART OF RECORD; hereafter “Sylwester”), Sijmons et. al. (Sijmons S, et. al. PLoS One. 2014 Apr 22;9(4):e95501. and associated deposit Sijmons S, et. al. Regulatory protein IE1 [Human betaherpesvirus 5]. GenBank: AHB19584.1. Dep. 29 Apr 2014.; CITED ART OF RECORD; hereafter “Sijmons”); Cobbold et. al. (US20140004081A1, Pub. 01/02/2014; CITED ART OF RECORD; hereafter “Cobbold”); Dander et. al. (Dander E, et. al. Exp Hematol. 2008 Apr;36(4):473-85. Epub 2008 Feb 8.; CITED ART OF RECORD; hereafter “Dander”); and Hall et. al. (Hall CE, et. al. PLoS One. 2017 Aug 11;12(8):e0178763.; CITED ART OF RECORD; hereafter “Hall”.)
The rationale behind this rejection was presented in a previous Office action and will not be repeated herein.
Response to Arguments
Applicant's arguments filed 04/28/2026 have been fully considered but they are not persuasive.
In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
Applicant first repeats that Sampson, as evidenced by Khanna, fails to teach or suggest the claimed peptide pool. This argument is not persuasive for reasons set forth supra. To reiterate and expand, Sampson expressly teaches CMV peptide pools, including pools comprising overlapping peptide sequences, and further teaches immunogenic compositions comprising such peptide pools (¶[0094][0097-0099]). Sampson also teaches that the peptide(s), including the pool of peptides, may be administered as a peptide or lipopeptide vaccine, optionally with an adjuvant (¶[0102]). Sampson further teaches HLA class I-restricted CTL epitopes and CD4+ determinants sufficient to facilitate T-helper function in the context of MHC Class II (¶[0093-0102]). Sampson also expressly incorporates the teachings of Khanna by reference for its teaching of CMV epitopes. Sampson states that CMV epitopes include, without limitation, peptides comprising amino acid sequences described by Trivedi and by Khanna, each incorporated by reference for their teaching of CMV epitopes (¶[0095]). Khanna teaches HCMV vaccine compositions comprising an effective amount of one or more immunologically active peptides (single epitopes or polyepitopes) in combination with a pharmaceutically acceptable carrier, excipient, diluent and/or adjuvant (¶[0256]). Khanna further identifies CMV antigens and epitopes, including pp50 and additional HCMV antigens, such as pp65, IE-1, gB, and gH, as targets of HCMV-specific T cell responses (¶[0339]). Therefore, this line of argument remains unpersuasive.
Applicant’s argument that the art fails to teach a pool limited to only the recited CMV antigens is also not commensurate in scope with the claim language. Again, to reiterate, the claims used open-ended “comprising” language and does not require that the pool only consist of SEQ ID NOs: 1-31, nor does it exclude additional CMV epitopes, additional CMV antigens, additional peptides, or additional immunogenic components. Additionally, Applicant’s own specification (¶[0036]) is drawn to full-length CMV proteins and polyepitope constructs reading on “peptides”. The claim merely requires that the pool comprise the recited peptide sequences and any generically recited adjuvant. Accordingly, teachings in the prior art of broader CMV peptide pools, overlapping CMV peptide libraries, and peptide compositions including the recited epitopes render the claims obvious even when the prior art also contemplates additional peptides and/or components.
Applicant argues that their peptide pools provided surprising and unexpected results, that there would be no reasonable expectation that the specific combination of peptides would yield the observed polyfunctional T cell responses, and that the clinical follow-up data in Tables 4-5 demonstrated a surprising reduction in disease, reduced need for antiviral therapy, or increased responsiveness to antiviral therapy.
To begin with, Applicant’s asserted unexpected results are not commensurate in scope with the claims. The claims broadly recite a peptide pool comprising SEQ ID NOs: 1-31 and “an adjuvant”. The claim is not limited to the specific peptide pool and specific adjuvanting compounds which provided the “unexpected results”, nor are the methods limited to only those conditions, such as the specific in vitro expansion conditions, cytokine supplementation, donor/patient population, treatment protocol, cell product, dosing regimen, assay conditions, and/or clinical endpoints relied upon by Applicant. Evidence that 20 of 21 patients expanded T cells under particular ex vivo conditions, or that such cells showed improved polyfunctionality, does not establish unexpected results across the full scope of the claimed peptide/adjuvant composition, methods of stimulating CTLs from any patient population, and/or methods of using any of said stimulated CTLs in any patient population. The only patients studied in the examples were those who had received solid organ transplants (SOTs) and received autologous adoptive T cell therapy (ACT), and it was unclear as to why in certain patients (e.g. the one patient whose T cells did not expand, or the two patients who failed to show improved response after receiving the ACT (¶[0123])) the therapy/method failed to work, such as possibly due to the immunocompromised status of said patient in order to prevent SOT rejection. There were no studies performed in other patient examples, such as CTL expansion from healthy, immunocompetent donors, the SOT patients receiving HLA-matched heterologous/allogenic ACT, ACT in congenital infections, or other immunocompromised subjects in need of CMV ACT, to effectively establish that the breadth of the claimed methods was commensurate with the singular example provided in the specification.
Applicant’s reliance on the asserted unexpected results is further unpersuasive because not only has Applicant failed to establish that the evidence is commensurate in scope with the pending claims, but Applicant has failed to establish that the alleged results are attributable to the claimed subject matter. Applicant argues at p. 6, ¶3 of the “Remarks” from 04/28/2026 that IL-21 and IL-2 supplementation during the T-cell expansion in the Examples were “standard components of T cell culture systems and do not account for the observed improvements in polyfunctionality and clinical outcomes. Rather, it is the composition of the claimed peptide pools that drives these results.” However, the specification’s working examples (starting with Example 1 at ¶[0113], Example 2 at ¶[0121] with respect to T-cell therapy Preparation; Example 3 at ¶[0123] with clinical outcomes following adoptive immunotherapy) identifies the relevant T-cell therapy preparation (Example 2) as stimulation of PBMCs with the clinical-grade CMV peptide pool in the presence of IL-21 on day 0, followed by supplementation with IL-2 on day 2 and every 3 days thereafter (¶[0121]). The same example reports successful expansion from 20 of 21 patients (¶[0122]), and the asserted improvement in polyfunctionality following in vitro expansion. Therefore, the relied upon data are tied to a specific ex vivo T-cell expansion protocol involving IL-21 and IL-2 supplementation, rather than to the broadly claimed peptide pool “comprising” the claimed peptides in combination with any “adjuvant”.
Applicant’s argument creates an additional problem. If IL-21 and IL-2 are not considered to be the claimed “adjuvant”, then the examples relied upon by Applicant do not appear to include any claimed adjuvant at all. The working example as noted supra describes PBMC stimulation with IL-21 and IL-2 with the CMV peptide pool, but does not identify the use of any other adjuvant such as alum, CpG ODN, monophosphoryl lipid A, MONTANIDE™, Pam3CSK4, quil A, or any other examples of adjuvants listed by the Applicant (¶[0055]) or known in the art at the time of filing. The specification defines “adjuvant” broadly and lists many different known adjuvants as examples, but the working example relied upon for unexpected results does not test any of those adjuvants with the claimed peptide pool. Under the definition at ¶[0055], IL-21 and/or IL-2 could be reasonably considered “immune modulatory proteins”, so it is unclear from Applicant’s statements if an additional, unrecited adjuvant was included in the Examples.
Conversely, if Applicant contends that IL-21 and IL-2 are indeed the claimed “adjuvant”, then the evidence remains non-commensurate in scope with the claim scope with respect to the unexpected results. The pending claimed composition broadly recites “an adjuvant” and is not limited to the cytokine(s) IL-21 and/or IL-2, or the dosing regimen performed in the instant Examples. Evidence obtained using a particular cytokine-supplemented ex vivo culture protocol does not establish unexpected results across the full genus of “adjuvants” claimed or across the full genus of methods of generating or using CTLs as claimed.
Applicant’s clinical outcome argument suffers from the same defect. The clinical follow-up data are expressly tied to adoptive immunotherapy using in vitro expanded CMV-specific T cells, not to administration of a broadly claimed peptide pool/adjuvant composition as a “vaccine”, which is another reasonable use or application of the compositions of claims 1-2. The specification reports that patients received adoptive CMV-specific T cell therapy and that clinical follow-up showed objective improvement, reduction or resolution of CMV reactivation/disease, reduced viral load, increased sensitivity to antiviral treatment, and the reduced need for any antiviral therapy in certain patients. Those outcomes are associated with the infused, expanded T cells and specific treatment protocol, not with every peptide pool/adjuvant composition encompassed by the pending claims. Accordingly, Applicant has failed to show a sufficient nexus between the full scope of the claimed compositions and methods of use thereof and the asserted unexpected results.
Applicant further argues that there would have been no reasonable expectation that the specific combination of peptides would yield the observed polyfunctional T cell responses. This argument is unpersuasive. First, there is no requirement that one should obtain Applicant’s exact asserted degree of polyfunctionality as that limitation is not recited in claim 1; only the inclusion of both class I and class II epitopes is required of the composition, there is no claimed outcome for said immunogenic peptides. Regardless, the inclusion of both types of epitopes in such a composition would result in a reasonable expectation of such immunogenic composition generating a polyfunctional immune response, especially in light of the prior art teachings. Although claim 7 is drawn to methods of generating polyfunctional CTLs, the applied prior art provides a reason to use CMV peptide pools comprising both class I and class II CMV epitopes to stimulate and expand CMV-specific T cells; again, with a reasonable expectation that such stimulation would generate polyfunctional CMV-specific CTLs. Sampson teaches CMV peptide pools, including pools comprising overlapping peptide sequences, and teaches immunogenic compositions and methods involving such peptide pools. As set forth supra, Sampson teaches the use of class I and CD4+ determinants to facilitate helper T cell function in the context of MHC class II, Sampson incorporates the teachings of Khanna, which also identifies multiple CMV antigens and epitopes relevant to cellular immune responses. The additional secondary references further teach specific CMV peptide sequences recited in the claims, teach overlapping peptide pools from relevant CMV antigens, teach programs designed to identify relevant antigens from CMV sequences, and teaches the incorporation of MHC class I and II antigens in said pools. Accordingly, the prior art taken in combination provides more than a general invitation to experiment; the prior art teaches the use of class I and class II epitopes for stimulating polyfunctional CMV-specific cellular immune responses.
Applicant’s evidence of improved polyfunctionality does not overcome the prima facie case because the evidence is not commensurate in scope with the claimed compositions or methods for reasons detailed supra. As the breadth of the instant claims is far larger than that of the tested compositions and methods, evidence obtained under those specific conditions does not establish that the full scope of the claimed methods would produce the asserted degree of polyfunctional CTL generation.
Accordingly, the question is not whether the prior art predicted Applicant’s reported percentage of successful expansion or the magnitude of post-expansion polyfunctionality. Rather, the question is whether the prior art would have provided a reason to use the claimed CVM peptide epitopes in a peptide pool to stimulate and expand CMV-specific CTLs with a reasonable expectation of successfully generating functional, CMV-specific T cells. Sampson, Khanna, Cobbold, Sylwester, Dander, and Sijmons collectively teach CMV sequences, peptide pools, the relevant CMV antigens, the specific CMV epitope sequences, class I and class II T cell epitope functionality, and CMV-specific cellular immune stimulation. Hall provides further teachings and motivation with algorithms/programs for identifying relevant CMV epitopes in order to screen or select peptides to avoid potential cross-reactivity with natural human peptides. Therefore, Applicant’s evidence and arguments regarding polyfunctionality do not outweigh the case of obviousness.
For at least these reasons, Applicants arguments are not persuasive, and the claims remain rejected as being obvious for the reasons outlined above.
Double Patenting
The text regarding nonstatutory double patenting was presented in a previous Office action.
(Rejection maintained.) Claims 1-2, 7, 9, 14-15, 17-18, 20-21, 23, 28, 33, 38, 43, 47, 93-95, and 99 remain provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-51 and 56-57 of copending Application No. 18/798,113 (reference application) in view of Sylwester and Khanna (supra). The rationale behind this rejection was set forth in a previous Office action and will not be repeated herein.
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.
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Smith CJ, et. al. Front Immunol. 2016 Sep 15;7:352. Provides information regarding adoptive T cell therapy (ACT) for treatment of CMV infection at the time of filing. Not utilized as rejection would be redundant to those set forth supra.
Walti CS, et. al. Transpl Int. 2023 Oct 12;36:11785. Post-filing review that speaks to ACT with respect to CMV infection.
THIS ACTION IS MADE FINAL. 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
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