DETAILED ACTION
Continued Examination Under 37 CFR 1.114
1. 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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 9/12/2025 has been entered.
2. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
3. Claims 56, 59, 60, 62, 69-73 and 86-93 are pending. Claims 1-55, 57, 58, 61, 63- 68 and 74-85 are canceled. Claims 62, 69-73 and 90-93 are withdrawn from consideration.
4. Claims 56, 59, 60 and 86-89 are under examination.
Priority
5. Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. Applicant has not complied with one or more conditions for receiving the benefit of an earlier filing date under 35 U.S.C. 119(e) as follows:
The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original nonprovisional application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of 35 U.S.C. 112(a) or the first paragraph of pre-AIA 35 U.S.C. 112, except for the best mode requirement. See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994).
The disclosure of the prior-filed applications, Application Nos. 62/687,191, 62/702,567, 62/726,804, 62/789,162, 62/800,700, 62/800,792 and 62/801,981 fails to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for one or more claims of this application.
Independent claim 56 recites “wherein the population of immune cells is a population of immune cells depleted of CD14 and CD25 expressing cells”. None of the above applications mentions depleting CD14 and CD25 expressing cells. Therefore, the claims are not entitled to the benefit of the earlier filing date of these applications. The effective filing date of the instant claims is 06/19/2019 (i.e. the PCT filing date).
Information Disclosure Statement
6. The information disclosure statement (IDS) submitted on 9/12/2025 has been considered by the examiner.
Rejection Withdrawn
7. The rejection of claims 56, 59, 60 and 86-89 under 35 U.S.C. 103 as being unpatentable over Rooney (WO2017/173321A1, pub. date: 10/5/2017, IDS filed on 5/8/2021), in view of Kaiser et al. (US 2017/0037370A1, pub. date: 2/9/2017, PTO-892 dated 5/13/2024) and Brasel et al (US 2002/0034517A1, pub. date: 3/21/2002, PTO-892 dated 5/13/2024) is withdrawn in view of applicant’s amendments and persuasive arguments.
New Grounds of Objecting and Rejection
Nucleotide and/or Amino Acid Sequence Disclosures
8. REQUIREMENTS FOR PATENT APPLICATIONS CONTAINING NUCLEOTIDE AND/OR AMINO ACID SEQUENCE DISCLOSURES
Items 1) and 2) provide general guidance related to requirements for sequence disclosures.
37 CFR 1.821(c) requires that patent applications which contain disclosures of nucleotide and/or amino acid sequences that fall within the definitions of 37 CFR 1.821(a) must contain a "Sequence Listing," as a separate part of the disclosure, which presents the nucleotide and/or amino acid sequences and associated information using the symbols and format in accordance with the requirements of 37 CFR 1.821 - 1.825. This "Sequence Listing" part of the disclosure may be submitted:
In accordance with 37 CFR 1.821(c)(1) via the USPTO patent electronic filing system (see Section I.1 of the Legal Framework for Patent Electronic System (https://www.uspto.gov/PatentLegalFramework), hereinafter "Legal Framework") as an ASCII text file, together with an incorporation-by-reference of the material in the ASCII text file in a separate paragraph of the specification as required by 37 CFR 1.823(b)(1) identifying:
the name of the ASCII text file;
ii) the date of creation; and
iii) the size of the ASCII text file in bytes;
In accordance with 37 CFR 1.821(c)(1) on read-only optical disc(s) as permitted by 37 CFR 1.52(e)(1)(ii), labeled according to 37 CFR 1.52(e)(5), with an incorporation-by-reference of the material in the ASCII text file according to 37 CFR 1.52(e)(8) and 37 CFR 1.823(b)(1) in a separate paragraph of the specification identifying:
the name of the ASCII text file;
the date of creation; and
the size of the ASCII text file in bytes;
In accordance with 37 CFR 1.821(c)(2) via the USPTO patent electronic filing system as a PDF file (not recommended); or
In accordance with 37 CFR 1.821(c)(3) on physical sheets of paper (not recommended).
When a “Sequence Listing” has been submitted as a PDF file as in 1(c) above (37 CFR 1.821(c)(2)) or on physical sheets of paper as in 1(d) above (37 CFR 1.821(c)(3)), 37 CFR 1.821(e)(1) requires a computer readable form (CRF) of the “Sequence Listing” in accordance with the requirements of 37 CFR 1.824.
If the "Sequence Listing" required by 37 CFR 1.821(c) is filed via the USPTO patent electronic filing system as a PDF, then 37 CFR 1.821(e)(1)(ii) or 1.821(e)(2)(ii) requires submission of a statement that the "Sequence Listing" content of the PDF copy and the CRF copy (the ASCII text file copy) are identical.
If the "Sequence Listing" required by 37 CFR 1.821(c) is filed on paper or read-only optical disc, then 37 CFR 1.821(e)(1)(ii) or 1.821(e)(2)(ii) requires submission of a statement that the "Sequence Listing" content of the paper or read-only optical disc copy and the CRF are identical.
9. Specific deficiency – Nucleotide and/or amino acid sequences appearing in the drawings are not identified by sequence identifiers in accordance with 37 CFR 1.821(d). Sequence identifiers for nucleotide and/or amino acid sequences must appear either in the drawings or in the Brief Description of the Drawings. See Fig. 6.
Moreover, it appears that the SEQ ID NOs mentioned in the description of Fig. 5 do not correlate with the sequences shown in Fig. 5.
Required response – Applicant must provide:
Replacement and annotated drawings in accordance with 37 CFR 1.121(d) inserting the required sequence identifiers;
AND/OR
A substitute specification in compliance with 37 CFR 1.52, 1.121(b)(3) and 1.125 inserting the required sequence identifiers into the Brief Description of the Drawings, consisting of:
A copy of the previously-submitted specification, with deletions shown with strikethrough or brackets and insertions shown with underlining (marked-up version);
A copy of the amended specification without markings (clean version); and
A statement that the substitute specification contains no new matter.
Specification
10. The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code, see paragraphs [0690], [0691], [0695] and [0752], for example. Applicant is required to delete the embedded hyperlink and/or other form of browser-executable code; references to websites should be limited to the top-level domain name without any prefix such as http:// or other browser-executable code. See MPEP § 608.01.
Claim Rejections - 35 USC § 103
11. 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.
12. Claims 56, 59, 60 and 86-89 are rejected under 35 U.S.C. 103 as being unpatentable over Rooney (WO2017/173321A1, pub. date: 10/5/2017, IDS filed on 5/8/2021), in view of Van Buuren et al (WO2019094642, pub date: 5/16/2019, effectively filed date: at least 11/9/2018, IDS filed on 5/16/2025).
The applied reference has a common assignee with the instant application. Based upon the earlier effectively filed date of the reference, it constitutes prior art under 35 U.S.C. 102(a)(2).
This rejection under 35 U.S.C. 103 might be overcome by: (1) a showing under 37 CFR 1.130(a) that the subject matter disclosed in the reference was obtained directly or indirectly from the inventor or a joint inventor of this application and is thus not prior art in accordance with 35 U.S.C.102(b)(2)(A); (2) a showing under 37 CFR 1.130(b) of a prior public disclosure under 35 U.S.C. 102(b)(2)(B); or (3) a statement pursuant to 35 U.S.C. 102(b)(2)(C) establishing that, not later than the effective filing date of the claimed invention, the subject matter disclosed and the claimed invention were either owned by the same person or subject to an obligation of assignment to the same person or subject to a joint research agreement. See generally MPEP § 717.02.
Regarding claim 56, Rooney teaches a method for activating tumor specific T cells comprising: isolating a population of T cells from a subject; and incubating the isolated population of T cells with antigen presenting cells and at least one neoantigenic peptide for a sufficient time to activate the T cells ([0024] and claim 137), wherein the at least on neoantigenic peptide is SEQ ID NO:60 (claim 1), wherein the T cell comprising a T cell receptor (TCR) capable of binding the at least one neoantigenic peptide or an MHC-peptide complex comprising the at least one neoantigenic peptide ([0023]).
Rooney teaches that peripheral blood mononuclear cells (PBMCs) isolated from a patient can be loaded with neoantigenic peptides or polynucleotides ex vivo ([0362]). The antigen presenting cells (APCs) (e.g. dendritic cells) or PBMCs are used to stimulate a T cell (e.g. an autologous T cell) ([0363]). The T cells are not genetically engineered. The amino acid sequence of SEQ ID NO:60 is 100% identical to instant SEQ ID NO:2, see sequence alignment below.
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Regarding claim 59, Rooney teaches that the polynucleotide encoding the neoantigenic peptide is mRNA ([0267]).
Regarding claim 60, Rooney teaches codon optimization of mRNA to increase mRNA stability and enhance translation ([0269]).
Regarding claim 86, Rooney teaches that the incubating the isolated population of T cells with antigen presenting cells and the at least one neoantigenic peptide is in the presence of IL2 and IL-7 (claims 137 and 157).
Regarding claim 87, Rooney teaches that CD107a are expressed on the cell surface of CD8+ T cells following activation with cognate peptide ([0630].
Regarding claim 88, Rooney teaches that the PBMCs are isolated from a patient and are autologous ([0362]), and the patient is a patient having a breast cancer with GATA3 mutation (page 155).
Rooney does not teach obtaining a population of immune cells which is PBMCs depleted of CD14 and CD25 expressing cells, and comprises a mixture of T cells and antigen presenting cells. Rooney does not teach stimulating the population of immune cells with FLT3L.
Regarding claim 56, Van Buuren et al teaches a method comprising:
(a) obtaining a biological sample from a subject comprising at least one APC and at least one T cell;
(b) depleting cells expressing CD14 and CD25 from the biological sample, thereby obtaining a CD14 and CD25 cell depleted sample;
(c) incubating the CD14 and CD25 cell depleted sample with FLT3L for a first time period;
(d) incubating at least one peptide with the CD14 and CD25 cell depleted sample of (c) for a second time period, thereby obtaining an APC peptide loaded sample;
(e) incubating the APC peptide loaded sample with the at least one T cell for a third time period,
thereby obtaining a first stimulated T cell sample (claim 49),
wherein the biological sample is PBMC ([0288]).
Van Buuren teaches that PBMCs can be loaded with neoantigen peptides or polynucleotides ex vivo ([0349).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of Rooney to obtain from PBMCs a population of immune cells depleted of CD14 and CD25 expressing cells, stimulate the population of immune cells with FLT3L, and contact the FLT3L stimulated population of immune cells with a GATA3 mutant peptide or a polynucleotide encoding a GATA3 mutant peptide to produce T cells which are specific to the GATA3 mutant peptide in view of Van Buuren. One of ordinary skill in the art would have been motivated to do so because the method of Van Buuren does not require separate isolation/preparation of T cells and antigen presenting cells (APC). One of ordinary skill in the art would have had a reasonable expectation of success because Van Burren teaches that their method is used to make T cells that are specific to a tumor antigen ([0391]). All the claimed elements were known in the prior art and one skill in the art could have combined the elements as claimed by known methods with no change in their respective function and the combination would have yield predictable results to one of ordinary skill in the art at the time of the invention ( see KSR International Co v Teleflex Inc., 550U.S.-, 82 USPQ2d 1385, 2007).
Regarding claim 89, contacting T cells with same GATA3 peptide (instant SEQ ID NO:2) in the presence of antigen presenting cells would have necessarily produced T cells having a TCR that recognizes the peptide:MHCcomplexs recited in the claim.
Double Patenting
13. The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
14. Claims 56, 59, 60 and 86-89 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-17 of U.S. Patent No. 11,162,072, in view of Rooney (WO2017/173321A1, pub. date: 10/5/2017, IDS filed on 5/8/2021).
Regarding claim 56, the claims of the patent disclose a method of preparing tumor antigen-specific T cells ex vivo suitable for use as an autologous therapy, the method comprising: (a) depleting CD14+ cells and CD25+ cells from a population of immune cells comprising antigen presenting cells (APCs) and T cells, thereby forming a CD14/CD25 depleted population of immune cells comprising a first population of APCs and T cells, wherein the population of immune cells is from a biological sample from a human subject with cancer; and (b) incubating the CD14/CD25 depleted population of immune cells for a first time period in the presence of: (i) FMS-like tyrosine kinase 3 receptor ligand (FLT3L), and (ii) (A) a polypeptide comprising at least two tumor antigen epitope sequences expressed by cancer cells of a human subject, wherein each of the at least two tumor antigen epitope sequences contains a mutation and binds to an MHC protein expressed by the subject with a stronger affinity than a corresponding wild-type epitope sequence, or (B) a polynucleotide encoding the polypeptide; thereby forming a population of stimulated T cells; and (c) expanding the population of stimulated T cells, thereby forming an expanded population of T cells (claim 1). A tumor antigen-specific T cells are T cells having a TCR that is specific to the tumor antigen.
Regarding claim 59, the claims of the patent disclose that the incubating comprises incubating the CD14/CD25/depleted population of immune cells in the presence of FLT3L and an RNA encoding the polypeptide (claims 11 and 12).
The claims of the patent do not disclose that the polypeptide is instant SEQ ID NO:2.
The teachings of Rooney have been set forth above as they apply to instant SEQ ID NO:2, claims 59, 60 and 86-88.
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have used the mutant GATA3 polypeptide such as instant SEQ ID NO:2 taught by Rooney as the polypeptide in the method of the patent in view of Rooney. One of ordinary skill in the art would have been motivated to do so with a reasonable expectation of success because the claims of the patent disclose a method of preparing tumor antigen-specific T cells ex vivo suitable for use as an autologous therapy, wherein the tumor antigen contains a mutation and binds to an MHC protein expressed by the subject with a stronger affinity than a corresponding wild-type epitope sequence, and Rooney teaches that the mutant GATA3 polypeptide including instant SEQ ID NO:2 can be used to make T cells which are specific for the mutant GATA3 polypeptide for treating cancer.
Regarding claim 89, contacting T cells with same GATA3 peptide (instant SEQ ID NO:2) in the presence of antigen presenting cells would have necessarily produced T cells having a TCR that recognizes the peptide:MHCcomplexs recited in the claim.
15. Claims 56, 59, 60 and 86-89 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-21 of U.S. Patent No. 12,258,581, in view of Rooney (WO2017/173321A1, pub. date: 10/5/2017, IDS filed on 5/8/2021).
Regarding claim 56, the claims of the patent disclose a method of preparing cancer antigen-specific T cells ex vivo suitable for T cell therapy in a human subject, the method comprising: (a) depleting CD25+ cells from a population of immune cells comprising antigen presenting cells (APCs) and T cells, thereby forming a depleted population of immune cells comprising a first population of APCs and T cells, wherein the population of immune cells is from a biological sample from a human subject; and (b) incubating the depleted population of immune cells for a first time period in the presence of: (i) FMS-like tyrosine kinase 3 receptor ligand (FLT3L), and (ii) (A) a polypeptide comprising one or more cancer antigen epitope sequences expressed by cancer cells of a human subject with cancer; or (B) a polynucleotide encoding the polypeptide comprising the one or more cancer antigen epitope sequences expressed by the cancer cells of the human subject with cancer; thereby forming a population of stimulated T cells; and (c) expanding the population of stimulated T cells, thereby forming an expanded population of T cells, wherein the expanded population of T cells comprises T cells that are specific to a complex comprising (i) a first cancer antigen epitope sequence of the one or more cancer antigen epitope sequences and (ii) an MHC protein expressed by the cancer cells or APCs of the human subject with cancer;
wherein depleting comprises contacting the population of immune cells with a CD25 binding agent and depleting further comprises depleting CD14+ cells from the population of immune cells,
wherein the biological sample is from the human subject with cancer and is a peripheral blood sample.
Regarding claim 59, the claims disclose that incubating comprises incubating the depleted population of immune cells in the presence of FLT3L and an RNA encoding the polypeptide.
Regarding claim 86, the claims disclose that the method further comprises stimulating one or more populations of APCs with one or more cytokines or growth factors, wherein the one or more cytokines or growth factors comprise GM-CSF, IL-4, FLT3L, TNF-α, IL-1β, PGE1, IL-6, IL-7, IFN-α, R848, LPS, ss-rna40, poly I:C, or a combination thereof.
The claims of the patent do not disclose that the polypeptide is instant SEQ ID NO:2.
The teachings of Rooney have been set forth above as they apply to instant SEQ ID NO:2, claims 60 and 86-88.
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have used the mutant GATA3 polypeptide such as instant SEQ ID NO:2 taught by Rooney as the polypeptide in the method of the patent in view of Rooney. One of ordinary skill in the art would have been motivated to do so with a reasonable expectation of success because the claims of the patent disclose a method of preparing tumor antigen-specific T cells ex vivo suitable for use as an autologous therapy, wherein the tumor antigen contains a mutation and binds to an MHC protein expressed by the subject with a stronger affinity than a corresponding wild-type epitope sequence, and Rooney teaches that the mutant GATA3 polypeptide including instant SEQ ID NO:2 can be used to make T cells which are specific for the mutant GATA3 polypeptide for treating cancer.
Regarding claim 89, contacting T cells with same GATA3 peptide (instant SEQ ID NO:2) in the presence of antigen presenting cells would have necessarily produced T cells having a TCR that recognizes the peptide:MHCcomplexs recited in the claim.
16. Claims 56, 59, 60 and 86-89 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of copending application No. 19/038,215, in view of Rooney (WO2017/173321A1, pub. date: 10/5/2017, IDS filed on 5/8/2021).
Regarding claim 56, the claims of the copending application disclose a method of preparing a T cell therapeutic comprising ex vivo expanded tumor antigen specific T cells, the method comprising:(a) depleting CD25+ cells from isolated peripheral blood mononuclear cells (PBMCs), thereby forming CD25 depleted PBMCs comprising a first population of APCs and T cells, wherein the isolated PBMCs are from a human subject with cancer; (b) incubating the CD25 depleted PBMCs for a first time period in the presence of:(A) a polypeptide comprising at least two tumor antigen epitope sequences expressed by cancer cells of the human subject, wherein each of the at least two tumor antigen epitope sequences contains a mutation and binds to an MHC protein expressed by the human subject with a stronger affinity than a corresponding wild-type epitope sequence, or (B) a polynucleotide encoding the polypeptide; thereby forming a population of stimulated T cells; and (c) expanding the population of stimulated T cells ex vivo,
wherein depleting further comprises depleting CD14+ cells from the isolated PBMCs, and depleting comprises contacting the isolated PBMCs with a CD14 binding agent.
Regarding claim 59, the polynucleotide encoding the polypeptide is an RNA.
Regarding claim 87, the incubating comprises incubating the CD14 depleted PBMCs in a first medium comprising at least one cytokine or growth factor for a first time period, wherein the one or more cytokine or growth factor comprises GM-CSF, IL-4, FLT3L, TNF-α, IL-1α, PGE1, IL-6, IFN-a, R848, or LPS.
The claims of the copending application do not disclose that the polypeptide is instant SEQ ID NO:2.
The teachings of Rooney have been set forth above as they apply to instant SEQ ID NO:2, claims 60 and 86-88.
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have used the mutant GATA3 polypeptide such as instant SEQ ID NO:2 taught by Rooney as the polypeptide in the method of the copending application in view of Rooney. One of ordinary skill in the art would have been motivated to do so with a reasonable expectation of success because the claims of the copending application disclose a method of preparing tumor antigen-specific T cells ex vivo suitable for use as an autologous therapy, wherein the tumor antigen contains a mutation and binds to an MHC protein expressed by the subject with a stronger affinity than a corresponding wild-type epitope sequence, and Rooney teaches that the mutant GATA3 polypeptide including instant SEQ ID NO:2 can be used to make T cells which are specific for the mutant GATA3 polypeptide for treating cancer.
Regarding claim 89, contacting T cells with same GATA3 peptide (instant SEQ ID NO:2) in the presence of antigen presenting cells would have necessarily produced T cells having a TCR that recognizes the peptide:MHCcomplexs recited in the claim.
17. Claims 56, 59, 60 and 86-89 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 77-100 of copending Application No. 17/599,468 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 77-100 of copending Application No. 17/599,468 (reference application) disclose a method of preparing a cell population, comprising contacting a cell population comprising T cells with antigen presenting cells (APCs) comprising one or more peptides containing at least one selected epitope sequence, wherein the at least one selected epitope sequence is selected from a library of epitope sequences, wherein each epitope sequence in the library is matched to a protein encoded by an HLA allele, and wherein each of the at least one selected epitope sequence satisfies at least two or three or each of the following criteria: (i) binds to a protein encoded by the HLA allele, (ii) is immunogenic according to an immunogenicity assay, (iii) is presented by APCs according to a mass spectrometry assay, and (iv) stimulates T cells to be cytotoxic according to a cytotoxicity assay; thereby producing antigen-specific T cells comprising a T cell receptor (TCR) that binds to a peptide-MHC complex, the peptide-MHC complex comprising the at least one selected epitope sequence and the matched protein encoded by an HLA allele,
the method further comprises depleting CD14+ cells and/or CD25+ cells from a population of immune cells comprising APCs and T cells prior to contacting the cell population comprising T cells with the APCs comprising the one or more peptides containing the at least one selected epitope sequence,
wherein the method further comprises incubating the CD14+ and/or CD25+ depleted cell population in the presence of (i) FMS-like tyrosine kinase 3 receptor ligand (FLT3L), and (ii) (A) a polypeptide comprising the at least one selected epitope sequence, or (B) a polynucleotide encoding the polypeptide; to form a cell population of cells comprising stimulated T cells,
wherein one or more of the at least one selected epitope sequence is from a protein overexpressed by a cancer cell of the subject, comprises a tumor specific mutation, is from a GATA3 protein, the at least one selected epitope sequence is selected from one or more epitope sequences of Table 1A-1F, Table 2A-2C, Table 3, Table 4A-4M, Table 5, Table 6, Table 7, Table 8, Table 11, Table 12, Table 13 and Table 14, which includes SEQ ID NO:111.
The amino acid sequence of SEQ ID NO:111 is identical to instant SEQ ID NO:2, see sequence alignment below.
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Regarding claim 89, contacting T cells with same GATA3 peptide (instant SEQ ID NO:2) in the presence of antigen presenting cells would have necessarily produced T cells having a TCR that recognizes the peptide:MHCcomplexs recited in the claim.
18. Claims 56, 59, 60 and 86-89 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 65-84 of copending application No. 17/609,705, in view of Rooney (WO2017/173321A1, pub. date: 10/5/2017, IDS filed on 5/8/2021).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Regarding claim 56, the claims of the copending application disclose a method of treating a cancer in a subject in need thereof, comprising:(a) depleting CD14+ cells and/or CD25+ cells from a population of immune cells comprising antigen presenting cells (APCs) and T cells, thereby forming a CD14 and/or CD25 depleted population of immune cells (PBMCs) comprising a first population of APCs and T cells, wherein the population of immune cells is from a biological sample from a human subject; (b) incubating the first population of APCs and T cells from step (a) for a first time period in the presence of:(i) FLT3L, and (ii) (A) a polypeptide comprising at least two different tumor antigen epitope sequences expressed by cancer cells of a human subject with cancer, or (B) a polynucleotide encoding the polypeptide; thereby forming a population of cells comprising stimulated T cells; (c) expanding the stimulated T cells from step (b), thereby forming an expanded population of cells comprising tumor antigen-specific T cells, wherein the tumor antigen-specific T cells comprise T cells that are specific to a complex comprising (i) a tumor antigen epitope sequence of the at least two different tumor antigen epitope sequences from step (b)(ii), and, (ii) an MHC protein expressed by the cancer cells or APCs of the human subject; and (d) administering the expanded population of cells from (c) to the human subject (claim 65), the biological sample is PBMC (claims 79 and 83).
Regarding claim 59, the polynucleotide encoding the polypeptide is mRNA.
Regarding claim 60, the mRNA is modified to increase immunogenicity (claims 66-69).
The claims of the copending application do not disclose that the polypeptide is instant SEQ ID NO:2.
The teachings of Rooney have been set forth above as they apply to instant SEQ ID NO:2, claims 60 and 86-88.
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have used the mutant GATA3 polypeptide such as instant SEQ ID NO:2 taught by Rooney as the polypeptide in the method of the copending application in view of Rooney. One of ordinary skill in the art would have been motivated to do so with a reasonable expectation of success because the claims of the copending application disclose a method of preparing tumor antigen-specific T cells ex vivo suitable for use in treating cancer, and Rooney teaches that the mutant GATA3 polypeptide including instant SEQ ID NO:2 can be used to make T cells which are specific for the mutant GATA3 polypeptide for treating cancer.
Regarding claim 89, contacting T cells with same GATA3 peptide (instant SEQ ID NO:2) in the presence of antigen presenting cells would have necessarily produced T cells having a TCR that recognizes the peptide:MHCcomplexs recited in the claim.
19. Claims 56, 59, 60 and 86-89 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 52-71 of copending application No. 18/701,073, in view of Rooney (WO2017/173321A1, pub. date: 10/5/2017, IDS filed on 5/8/2021).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Regarding claim 56, the claims of the copending application disclose a method of treating ovarian cancer in a human subject in need thereof comprising:(a) depleting CD14+ cells and/or CD25+ cells from a population of immune cells from the human subject comprising antigen presenting cells (APCs) and T cells, thereby forming a CD14 and/or CD25 depleted population of immune cells comprising a first population of APCs and T cells; (b) incubating the first population of APCs and T cells from step (a) for a first time period in the presence of: (i) FMS-like tyrosine kinase 3 receptor ligand (FLT3L), and (ii) a first polynucleotide encoding a first polypeptide comprising two or more short epitope sequences and a second polynucleotide encoding a second polypeptide; thereby forming a population of cells comprising stimulated T cells; and (c) expanding the population of cells comprising stimulated T cells, thereby forming an expanded population of cells comprising tumor antigen-specific T cells, wherein the tumor antigen-specific T cells comprise T cells that are specific to a complex comprising (i) the at least one tumor antigen epitope sequence and (ii) an MHC protein expressed by the cancer cells or APCs of the human subject of (b)(ii); and (d) administering the expanded population of cells from (c) to the human subject, wherein the human subject has ovarian cancer.
Regarding claim 59, the first polynucleotide is a first mRNA and the second polynucleotide is a second mRNA.
The claims of the copending application do not disclose that the polypeptide is instant SEQ ID NO:2.
The teachings of Rooney have been set forth above as they apply to instant SEQ ID NO:2, claims 60 and 86-88.
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have used the mutant GATA3 polypeptide such as SEQ ID NO:2 taught by Rooney as the polypeptide in the method of the copending application in view of Rooney. One of ordinary skill in the art would have been motivated to do so with a reasonable expectation of success because the claims of the copending application disclose a method of preparing tumor antigen-specific T cells ex vivo suitable for treating cancer, and Rooney teaches that the mutant GATA3 polypeptide is used to make T cells which are specific for the mutant GATA3 polypeptide for treating cancer.
Regarding claim 89, contacting T cells with same GATA3 peptide (instant SEQ ID NO:2) in the presence of antigen presenting cells would have necessarily produced T cells having a TCR that recognizes the peptide:MHCcomplexs recited in the claim.
Conclusion
20. No claims are allowed.
21. Any inquiry concerning this communication or earlier communications from the examiner should be directed to HONG SANG whose telephone number is (571)272-8145. The examiner can normally be reached Monday-Friday 8am-5pm.
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/HONG SANG/Primary Examiner, Art Unit 1646