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 .
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.
Election/Restrictions
Applicant's election with traverse of SEQ ID NO: 53 in the reply filed on 10/16/25 is acknowledged. The traversal is on the ground(s) that the Office provided no specific reasons or evidence to establish that any of the peptide sequences are patentably distinct.
This is not found persuasive because as noted in the requirement for restriction a Markush group for alternative of chemical compounds are considered to when following criteria are fulfilled: (A) all alternatives have a common property or activity; AND (B)(1) a common structure is present, that is, a significant structural element is shared by all of the alternatives; OR (B)(2) in cases where the common structure cannot be the unifying criteria, all alternatives belong to a recognized class of chemical compounds in the art to which the invention pertains. The phrase "significant structural element is shared by all of the alternatives" refers to cases where the compounds share a common chemical structure which occupies a large portion of their structures, or in case the compounds have in common only a small portion of their structures, the commonly shared structure constitutes a structurally distinctive portion in view of existing prior art, and the common structure is essential to the common property or activity. The phrase "recognized class of chemical compounds" means that there is an expectation from the knowledge in the art that members of the class will behave in the same way in the context of the claimed invention, i.e. each member could be substituted one for the other, with the expectation that the same intended result would be achieved. The chemical compounds of peptide antigens are not regarded as being of similar nature because all of the alternatives do not share a common property or activity. The recited peptide antigens include each of SARS-CoV-2 membrane proteins, a segment of SARS-CoV-2 nucleocapsid protein, a segment of SARSV-CoV-2 spike protein. These peptides have different sequences without a common structure or activity.
The requirement is still deemed proper and is therefore made FINAL.
Claims 91-109 are currently pending.
Claims 91-94, 97-109 are elected as reading on the elected species of SARS-CoV-2 Membrane Peptide 37 (SEQ ID NO:53).
Claims 95-96 are withdrawn as directed to non-elected species.
Claim Interpretation
Claim 102 contains the limitation “optionally further comprising administering said SARS-COV-2 antigen specific T-cells to a subject in need thereof”. This limitation is interpreted as an optional limitation as per MPEP § 2173.05 (h), and is not considered in the patentability analysis.
Claim 107 contains the limitations “optionally with IL-2”, “optionally other cytokines”, “optionally, repeating (g) one or more times”, and “(i) optionally separating the isolated T cells… to a subject tin need thereof”. These limitations are interpreted as optional limitations as per MPEP § 2173.05 (h), and are not considered in the patentability analysis.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 98, 105, 107-109 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 98 contains the limitation “are no more than a control value from an uninfected or unvaccinated subject”. It is unclear what this limitation is intending to convey.
Claim 105 contains the limitation “are no more than a control value from an uninfected or unvaccinated subject”. It is unclear what this limitation is intending to convey.
Claim 107 contains the limitation “which may be nonadherent cells, CD3+ cells”. It is unclear if this limitation is a required limitation of the claim. Further it is unclear if this limitation is indicating that the nonadherent cells are CD3+, or if they are two distinct population of cells which may be separated.
Claim 107 contains the limitation “which may be adherent cells, C11C+ cells or CD14 cells”. It is unclear if this limitation is a required limitation of the claim. It appears that the limitation CD14 is missing a designation (e.g., +/-). Further it is unclear if this limitation is indicating that the nonadherent cells are either C11C+ cells or CD14 cells, or if they are three distinct population of cells which may be separated.
The term “sufficient” in claim sufficient is a relative term which renders the claim indefinite. The term “sufficient” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. A skilled artisan would not be reasonable apprised how much growth inhibition would be required to be considered “sufficient”.
Claim 107 contains the limitation “are no more than a control value from an uninfected or unvaccinated subject”. It is unclear what this limitation is intending to convey.
Claim Rejections - 35 USC § 103
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 91-94, 97, 99-101 is/are rejected under 35 U.S.C. 103 as being obvious over De Groot et al., US Publication No. 2023/0190915 (earliest priority dated 2/14/20, hereinafter De Groot) in view of Leen et al., (2014) Antiviral T-cell therapy. Immunological Reviews, 258(1):12-29 (cited on IDS dated 9/23/22, hereinafter Leen).
Regarding claim 91, De Groot discloses antigen-specific, SARS-CoV-2 T cell compositions, methods of making, and methods of using thereof (Abstract, [0011]-[0012]). De Groot discloses isolating T cells from a subject and culturing in the presence of one or more polypeptides of interest and exogenous growth promoting cytokines for a time sufficient to be activated by the polypeptide ([0227]-[0231], [0244]-[0245]). The polypeptides are preferably derived from SARS-CoV-2 proteins, such as membrane proteins ([0101]). Following exposure to the polypeptide, production of IFN-γ is detected to determine the cell mediated immune response of the cells ([0217], [0221]).
Regarding claims 92-94, De Groot discloses that in some embodiments the peptide may comprise SEQ ID NO: 21 or a fragment thereof ([0011]; amino acids 6 to 21 of SEQ ID NO: 21 corresponds 100% to SEQ ID NO:53 of the present application).
Regarding claim 101, In some embodiments, De Groot discloses identifying and isolating CD8+ or CD4+ T cells for use in the disclosed methods ([0228]).
Regarding claim 102, De Groot discloses that the T cells are preferably peripheral blood mononuclear cells (PMBCs) ([0228]).
Regarding claims 97-99, De Groot discloses that the cell may be derived from a subject known to have had Covid-19 ([0228]).
De Groot does not disclose treating a subject by administering the SARS-Cov-2 T cells to the subject.
Leen reviews methods of treating a subject infected with, at risk of infection with a virus by administering antigen specific T cells (Abstract). Leen discloses exposing peripheral blood mononuclear cells (PMBCs) to at least one peptide of interest to generated antigen specific T cells which secrete IFN-γ in response to stimulation with the peptide (IFNγ capture). The T cells are then administered to a subject in need thereof (IFNγ capture). Leen explain that clinical trials of IFN-γ capture based approach have been shown to be safe and effective treatments for viral infections (IFNγ capture).
Regarding claim 97, the combination does not explicitly disclose that the antibody levels of the subject to the SARS-CoV-2 antigens are greater than a control value. However, De Groot discloses that the cell may be derived from a subject known to have had Covid-19 ([0228]). Therefore, it is implicit that, at least in some embodiments, that a subject known to have had Covid-19 would have antibody levels of the SARS-CoV-2 antigen greater than that of a control value.
Regarding claim 100, the combination does not disclose that the antigen-specific T cells are non-autologous and share at least one major histocompatibility with the subject. However, Leen explains that an advantage of IFN-γ capture based approach is that it can be used irrespective of HLA haplotypes, but that individualized multimers could be made for the HLA haplotypes. Therefore, there is a suggestion present that in Leen that the antigen specific T cells could be haplotype specific.
Claims 102-106 is/are rejected under 35 U.S.C. 103 as being obvious over Lazarski et al., (2019) Designing a high throughput multi-parameter assay for process development of antigen specific T cell therapy products. Cytotherapy, 21(5) Supp: S17 (hereinafter Lazarski) in view of De Groot.
Regarding claim 102, Lazarski discloses methods for rapid production of antigen specific T cell therapy products. Lazarski discloses culturing donor PMBCs with viral peptides and combinations of cytokines including IL-4 and IL-7 (Methods, Results & Conclusion). The cultured cells are subsequently evaluated for IFN-γ release for antigen specific response (Methods, Results & Conclusion). Lazarski explains that CD4+ T cells cultured in IL-4 and IL-7 demonstrate significantly improved expansion as compared to controls (Methods, Results & Conclusion). Lazarski concludes that the disclosed methods optimize production of viral antigen specific T cells (Methods, Results & Conclusion).
Lazarski does not disclose that the viral peptide is a SARS-CoV-2 protein.
De Groot discloses compositions and methods for treating SARS-CoV-2 (Abstract). De Groot explains that there is an urgent need for effective pharmaceuticals for the treatment of Covid-19 ([0005]-[0010]). In particular De Groot discloses therapeutic T cell epitope compounds such as SEQ ID NO: 21 or a fragment thereof ([0011]; amino acids 6 to 21 of SEQ ID NO: 21 corresponds 100% to SEQ ID NO:53 of the present application).
As both Lazarski and De Groot are directed to methods of producing viral antigen specific T cells it would be obvious to one of ordinary skill in the art that the references could be combined. A skilled artisan would understand that the SARS-CoV-2 membrane protein of De Groot could be used in the methods of Lazarski as a simple substitution of one known viral peptide antigen for another. A skilled artisan would further be motivated to use the cytokines disclosed by Lazarski for optimized T cell production as taught by Lazarski.
Claims 107-109 is/are rejected under 35 U.S.C. 103 as being obvious over Bollard et al., US Publication No. 2018/0072990 (hereinafter Bollard) in view of De Groot.
Regarding claims 107-108, Bollard discloses methods for producing virus-specific T cells (Abstract). Bollard explains that virus-specific, antigen specific T cells may safely and effectively treat viral infections ([0008]-[0010]).
Bollard discloses (a) dividing mononuclear cells from a cord blood sample or other sample of naïve immune cells into two portions; (b) contacting a first portion of said sample with PHA or another mitogen and, optionally with IL-2, to produce ATCs (“activated T cells”) and treating the ATCs with radiation or another agent to inhibit their outgrowth; (c) separating non-adherent T-cells and T-cell precursor cells from adherent dendritic cells and dendritic precursor cells); (d) cryopreserving or otherwise reserving the non-adherent cells; (e) contacting the adherent cells in the second portion with IL-4 and GM-CSF or other cytokine(s) and/or other agent(s) that generate and mature dendritic cells and with at least one peptide antigen to produce antigen-presenting dendritic cells that present the at least one peptide antigen, and treating said antigen-presenting dendritic cells with radiation or another agent sufficient to inhibit their outgrowth; (f) contacting the cryopreserved or otherwise reserved non-adherent cells from (d) with the dendritic antigen-presenting cells produced in (e) in the presence of IL-7 and IL-15 to produce antigen-specific T-cells that recognize the at least one peptide antigen; (g) contacting the antigen-specific T-cells produced by (f) with the ATCs of (b) in the presence of the at least one peptide antigen in the presence if K562 cells or other accessory cells and in the presence of IL-15; optionally, repeating (g) one or more times; (h) recovering the antigen-specific T-cells that recognize the at least one peptide antigen; and(i) optionally, administering said antigen-specific T-cells to a subject in need thereof or banking or storing said antigen-specific T-cells ([0017], claim 1).
Bollard does not disclose that the peptide is a SARS-CoV-2 protein.
De Groot discloses compositions and methods for treating SARS-CoV-2 (Abstract). De Groot explains that there is an urgent need for effective pharmaceuticals for the treatment of Covid-19 ([0005]-[0010]). In particular De Groot discloses therapeutic T cell epitope compounds such as SEQ ID NO: 21 or a fragment thereof ([0011]; amino acids 6 to 21 of SEQ ID NO: 21 corresponds 100% to SEQ ID NO:53 of the present application).
As both Bollard and De Groot are directed to methods of treating viral infections it would be obvious to one of ordinary skill in the art that the references could be combined. A skilled artisan would understand that the SARS-CoV-2 membrane protein of De Groot could be used in the methods of Bollard as a simple substitution of one known viral peptide antigen for another.
Regarding claim 109, the combination does not explicitly disclose that the antibody levels of the subject to the SARS-CoV-2 antigens are greater than a control value. However, De Groot discloses that the cell may be derived from a subject known to have had Covid-19 ([0228]). Therefore, it is implicit that, at least in some embodiments, that a subject known to have had Covid-19 would have antibody levels of the SARS-CoV-2 antigen greater than that of a control value.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KARA D JOHNSON whose telephone number is (571)270-1414. The examiner can normally be reached Monday-Friday 8:00-4:00 CT.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Peter Paras can be reached at (571) 272-4517. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/KARA D JOHNSON/Primary Examiner, Art Unit 1632
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