DETAILED ACTION
Notice of Pre-AIA or AIA Status
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
2. Applicant’s species election without traverse of (i) SEQ ID NO:27, (ii) SEQ ID NO:5 and (iii) SEQ ID NO:76 in the reply filed on 5/8/2026 is acknowledged. Claims 35 and 59-83 are pending. Claims 1-34 and 36-58 are canceled. Claims 67-76 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 5/8/2026.
3. Claims 35, 59-66 and 77-83 are under examination.
Information Disclosure Statement
4. The information disclosure statement (IDS) submitted on 1/31/2024, 2/1/2024 and 1/12/2026 have been considered by the examiner.
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. 62,812,799 and 62,894,659, 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.
Claim 63 recites SEQ ID NOs: 168-169. Application Nos. 62,812,799 and 62,894,659 do not disclose a PD-1 ectodomain comprises SEQ ID NO: 168 or 169. Therefore, the effective filing date of claim 63 is the filing date of Application No. 62980737, i.e. 2/24/2020.
Claim Rejections - 35 USC § 102
6. The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
7. Claims 35, 59-61, 63, 65-66 and 77-83 are rejected under 35 U.S.C. 102(a)(2) and claim 63 is also rejected under 35 U.S.C. 102(a)(1) as being anticipated by (i) Nager et al. (WO 2019/169290A1, pub. date: 9/6/2019, effectively filed date: 3/2/2018, IDS filed on 1/31/2024) or (ii) Nager et al. (US 2019/0292533, pub. date: 9/26/2019, effectively filed date: 3/2/2018, IDS filed on 1/12/2026).
The applied reference has a common inventor/applicant 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. 102(a)(2) 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) if the same invention is not being claimed; 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 in the reference 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.
Regarding claims 35 and 77, WO 2019/169290A1 discloses a polynucleotide encoding an inducible chimeric cytokine receptor ([0041]), wherein the inducible chimeric cytokine receptor comprising: a dimerization domain; a tyrosine kinase activating domain; and a tyrosine effector domain ([0007]), wherein the dimerization domain is derived from thrombopoietin receptor (TPOR) ([0020]), the dimerization domain comprises an extracellular domain of PD-1 ([0224]), wherein the tyrosine kinase activating domain comprises a transmembrane domain and a Janus Kinase (JAK) binding domain ([0008]), the transmembrane domain comprises a transmembrane domain derived from TPOR/MPLR ([0026]), the JAK binding domain is derived from TPOR/MPLR ([0022]), the JAK is JAK2 ([0235]), the transmembrane and JAK2 binding domain are from a thrombopoietin receptor (TPOR/MPLR 478-528) ([0241]), the tyrosine effector domain comprises a STAT-activation domain of at least one receptor ([0010]), two cytokine receptors ([0254]), the tyrosine kinase activating domain comprises a polypeptide of IL2Rb (339-379, 393-433, 518-551) ([0430]), the tyrosine kinase activating domain comprises SEQ ID NO:116 ([0024]).
The amino acid sequence of SEQ ID NO:116 is 100% identical to instant SEQ ID NO: 27, see sequence alignment below:
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395
808
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250
799
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Regarding claim 59, WO 2019/169290A1 teaches that the chimeric cytokine receptor is a dimer comprising an extracellular domain of PD-1 ([0224]).
Regarding claims 60-61 and 63, WO 2019/169290A1 teaches that the PD-1 extracellular domain is derived from PD-1 extracellular domain, which implies both wild type and mutant thereof. The wild type PD-1 would inherently comprise instant SEQ ID NO: 5 (wild type PD1 extracellular domain).
Regarding claim 65, WO 2019/169290A1 teaches that the JAK binding domain is derived from TPOR/MPLR ([0022]), and the JAK is JAK2 ([0235]).
Regarding claims 66 and 78, WO 2019/169290A1 teaches that the tyrosine effector domain comprises SEQ ID NO: 166 ([0035]). The amino acid sequence of SEQ ID NO:166 is 100% identical to instant SEQ ID NO:77, and comprises instant SEQ ID NO:76, see sequence alignment below:
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398
794
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247
832
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255
784
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Regarding claim 79, WO 2019/169290A1 teaches an expression vector comprising a polynucleotide encoding the inducible chimeric cytokine receptor ([0043]).
Regarding claim 80, WO 2019/169290A1 teaches an engineered immune cell comprising at least one polynucleotide encoding inducible chimeric cytokine receptor ([0043]).
Regarding claim 81, WO 2019/169290A1 teaches a method of preparing an engineered immune cell, the method comprising introducing a polynucleotide or an expression vector comprising a polynucleotide encoding an inducible chimeric cytokine receptor in an immune cell ([0049]).
Regarding claim 82, WO 2019/169290A1 teaches a pharmaceutical composition
comprising the isolated immune cell ([0064]).
Regarding claim 83, WO 2019/169290A1 teaches a kit comprising one or more containers comprising an isolated immune cell comprising one or more polynucleotide(s) encoding an inducible chimeric cytokine receptor ([0337]).
Note that the teachings of US 2019/0292533 are identical to WO2019/169290A1.
Claim Rejections - 35 USC § 103
8. 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.
9. Claims 35, 59-63, 65-66 and 77-83 are rejected under 35 U.S.C. 103 as being obvious over (i) Nager et al. (WO 2019/169290A1, pub. date: 9/6/2019, effectively filed date: 3/2/2018, IDS filed on 1/31/2024) or (ii) Nager et al. (US 2019/0292533, pub. date: 9/26/2019, effectively filed date: 3/2/2018, IDS filed on 1/12/2026), in view of Zhao et al. (WO2019/118508A1, pub. date: 6/20/2019, effectively filed date: 12/12/2017, IDS filed on 1/31/2024).
The applied reference has a common applicant/inventor 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.
The teachings of Nager have been set forth above as they apply to claims 35, 59-61, 63, 65-66 and 77-83.
Regarding claim 62, Nager does not teach that the PD-1 has high binding affinity as compared to the wild type PD-1.
Zhao teaches a modified T cell comprising an exogenous TCR and a switch receptor, wherein the switch receptor comprises the extracellular domain of a variant of PD-1, a CD8alpha transmembrane domain and 4-1BB cytoplasmic domain, wherein the variant of PD-1 has an alanine-to leucine substitution at amino acid position 132 relative to the wild type PD-1 amino acid sequence and is a high affinity PD-1, and the switch receptor enhances the exogenous TCR T cell function (Example 5).
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 chimeric cytokine receptor taught by Nager to use the high affinity PD-1 in view of Zhao. One of ordinary skill in the art would have been motivated to do so because high affinity PD1 has higher binding affinity to its ligand (PD-L1 and/or PD-L2) as compared to wild type PD-1. One of ordinary skill in the art would have had a reasonable expectation of success because Zhao teaches that the switch receptor comprising the extracellular domain of a high affinity PD-1 enhances the exogenous TCR T cell function (Example 5).
10. Claims 35, 59-61, 63-66 and 77-83 are rejected under 35 U.S.C. 103 as being obvious over (i) Nager et al. (WO 2019/169290A1, pub. date: 9/6/2019, effectively filed date: 3/2/2018, IDS filed on 1/31/2024) or (ii) Nager et al. (US 2019/0292533, pub. date: 9/26/2019, effectively filed date: 3/2/2018, IDS filed on 1/12/2026), in view of Pule et al. (WO2017/029512A1, pub. date: 2/23/2017, IDS filed on 1/31/2024), and Xie et al. (Oncology Letter, 2018, 16:157-166, IDS filed on 2/1/2024).
The applied reference has a common applicant/inventor 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.
The teachings of Nager have been set forth above as they apply to claims 35, 59-61, 63, 65-66 and 77-83.
Regarding claim 64, Nager does not teach that a chimeric cytokine receptor comprises an extracellular domain comprising a scFv which binds specifically to PD-L1 or PD-L2.
Pule et al. teaches a chimeric cytokine receptor (CCR) comprises a ligand binding exodomain which binds to a ligand such as a cell-surface antigen, a transmembrane domain and a cytokine-receptor endodomain (abstract, page 16, lines 30-34), the ligand is PD-L1 (page 30, line 13), when the CCR binds its ligand, the JAK-STAT pathway is initiated (page 17, lines 8-10), the CCR comprise the IL-2 receptor beta chain/or IL-2 receptor gamma chain (page 19, lines 19-20), the CCR comprises two antigen-binding domains (page 6, lines 24-34), two cytokine receptor endodomains (page 7, lines 1-9), the CCR further comprises a first dimerization domain and a second dimerization domain, wherein the first and second dimerization domains either dimerize spontaneously or in the presence of a chemical inducer of dimerization (page 12 and Fig. 3), wherein the exodomain is an antigen binding domain selected from scFv or binding domain of a natural receptor (abstract and page 23, lines 1-21). For the ligand PD-L1, the exodomain would be scFv that binds to PD-L1, or a binding domain of PD-L1’s natural receptor PD-1.
Xie et al. teaches a chimeric antigen receptor comprising a scFv that binds to PD-L1.
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 PD-1 chimeric cytokine receptor taught by Nager to substitute the PD-L1 scFv for PD-1 extracellular domain in view of Pule. One of ordinary skill in the art would have been motivated to do so because Pule et al. teaches that the extracellular domain of a chimeric cytokine receptor can be either a scFv or a binding domain of a natural receptor (abstract and page 23, para 23), and the binding domain of PD-1 and anti-PD-L1 scFv both bind to PD-L1. One of ordinary skill in the art would have had a reasonable expectation of success because Pule et al. teaches making a chimeric cytokine receptor comprises an exodomain which is scFv, and Xie teaches an anti-PD-L1 scFv.
Double Patenting
11. 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 USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The 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/process/file/efs/guidance/eTD-info-I.jsp.
12. Claims 35, 59-66 and 77-83 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-40 of U.S. Patent No. 12,528,856 B2, in view of Pule et al. (WO2017/029512A1, pub. date: 2/23/2017, IDS filed on 1/31/2024).
The claims of the patent disclose an inducible chimeric cytokine receptor comprising: a) a binding domain comprising an extracellular portion of a TGF-β receptor, or a TGF-β antigen binding domain; b) a transmembrane domain; c) an intracellular Janus Kinase (JAK)-binding domain; and d) an intracellular recruiting domain, wherein the transmembrane domain and the intracellular JAK-binding domain is a fragment of a variant of the full-length thrombopoietin receptor/myeloproliferative leukemia protein receptor (TPOR/MPLR) as shown in SEQ ID NO: 26, wherein the fragment is selected from the group consisting of SEQ ID NO: 30-71, 73-79, 160, and 217-234, and wherein the intracellular recruiting domain is a STAT-recruiting domain, wherein the STAT-recruiting domain is IL12Rb1, IL12Rb2, or IL2Rb, wherein the STAT-recruiting domain comprises any one of the amino acid sequences of SEQ ID NO: 80-SEQ ID NO: 122 and SEQ ID NO: 161, wherein the chimeric cytokine receptor is a dimerized chimeric cytokine receptor comprising monomers that each comprise a) to d), wherein the transmembrane domain and intracellular JAK-binding domain comprises an amino acid sequence selected from the group consisting of SEQ ID NO: 37-40, 53-56, 44-45, 64 and 70.
The claims of the patent further disclose a polynucleotide encoding the chimeric cytokine receptor, an expression vector comprising the polynucleotide, an engineered immune cell comprising the vector, a method of preparing an engineered immune cell, the method comprising introducing the polynucleotide into an immune cell, an engineered immune cell expressing the chimeric cytokine receptor, a pharmaceutical composition comprising the immune cells and a kit comprising the pharmaceutical composition, wherein the immune cell is selected from the group consisting of: T-cell, dendritic cell, killer dendritic cell, mast cell, NK-cell, macrophage, monocyte, B-cell and an immune cell derived from a stem cell, wherein the chimeric cytokine receptor comprising the amino acid sequence selected from SEQ ID NOs: 124-151 and SEQ ID NOs: 163-216.
Each of SEQ ID NOs: 40, 134, 182 and 212 comprises instant SEQ ID NO: 27.
Each of SEQ ID NOs: 111, 112, 167, 168 comprises instant SEQ ID NO: 76.
The claims of the patent do not disclose that the chimeric cytokine receptor comprising a binding domain comprising an extracellular portion of a PD1 protein or a PD-L1 antigen binding domain.
Pule et al. teaches a chimeric cytokine receptor (CCR) comprises a ligand binding exodomain which binds to a ligand such as a cell-surface antigen, a transmembrane domain and a cytokine-receptor endodomain (abstract, page 16, lines 30-34), the ligand is PD-L1 (page 30, line 13), when the CCR binds its ligand, the JAK-STAT pathway is initiated (page 17, lines 8-10), the CCR comprise the IL-2 receptor beta chain/or IL-2 receptor gamma chain (page 19, lines 19-20), the CCR comprises two antigen-binding domains (page 6, lines 24-34), two cytokine receptor endodomains (page 7, lines 1-9), the CCR further comprises a first dimerization domain and a second dimerization domain, wherein the first and second dimerization domains either dimerize spontaneously or in the presence of a chemical inducer of dimerization (page 12 and Fig. 3), wherein the exodomain is an antigen binding domain selected from scFv or binding domain of a natural receptor (abstract and page 23, lines 1-21). For the ligand PD-L1, the exodomain would be scFv that binds to PD-L1, or a binding domain of PD-L1’s natural receptor PD-1.
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 made a chimeric cytokine receptor comprising a binding domain comprising an extracellular portion of a PD1 protein or antigen binding domain of an PD-L1 antibody such as scFv in view of the claims of the patent and Pule. One of ordinary skill in the art would have been motivated to do so with a reasonable expectation of success because Pule teaches chimeric cytokine receptor having similar structure and binding to PD-L1.
13. Claims 35, 59-65, 77 and 79-83 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-11 of copending Application No. 19/551,160, in view of Pule et al. (WO2017/029512A1, pub. date: 2/23/2017, IDS filed on 1/31/2024).
This is a provisional nonstatutory double patenting rejection.
The claims of copending application disclose a PD-1 chimeric cytokine receptor comprising: a. a PD-1 ectodomain or a PD-L1 antigen binding domain of an anti-PD-L1 or an anti-PD-L2 antibody; b. a transmembrane domain and a Janus Kinase (JAK)-binding domain comprising SEQ ID NO: 40, SEQ ID NO: 23, SEQ ID NO: 24, SEQ ID NO: 25, SEQ ID NO: 26, or SEQ ID NO: 27; and c. a STAT recruiting domain comprising a STAT-recruiting domain from a receptor selected from the group consisting of BLNK, IL2RG, EGFR, EpoR, GHR, IFNAR1, IFNAR2, IFNAR1/2, IFNLR1, IL10R1, IL12Rb1, IL12Rb2, IL21R, IL2small, IL7R, IL7Ra, IL9R, IL15R, and IL21R, wherein the PD-1 ectodomain comprises a wild type PD-1 ectodomain sequence or comprises one or more mutations to the wild type PD-1 ectodomain sequence, the PD-1 ectodomain comprising one or more mutations has a higher binding affinity for its ligand than a wild type PD-1 ectodomain, wherein the PD-1 ectodomain comprises an amino acid sequence selected from SEQ ID NOs: 2-5, 132-133, and 168-169, wherein the PD-L1 antigen binding domain is an scFv.
The amino acid sequences of SEQ ID NOs: 40, 23-27, 2-5, 132-133, and 168-169 are 100% identical to those of SEQ ID NOs: 40, 23-27, 2-5, 132-133, and 168-169, respectively as the copending application is a continuation of instant application.
The claims of the copending applicant does not teach that the STAT-recruiting domain is from IL2Rb.
Pule et al. teaches a chimeric cytokine receptor (CCR) comprises a ligand binding exodomain which binds to a ligand such as a cell-surface antigen, a transmembrane domain and a cytokine-receptor endodomain (abstract, page 16, lines 30-34), the ligand is PD-L1 (page 30, line 13), when the CCR binds its ligand, the JAK-STAT pathway is initiated (page 17, lines 8-10), the CCR comprise the IL-2 receptor beta chain/or IL-2 receptor gamma chain (page 19, lines 19-20), the CCR comprises two antigen-binding domains (page 6, lines 24-34), two cytokine receptor endodomains (page 7, lines 1-9), the CCR further comprises a first dimerization domain and a second dimerization domain, wherein the first and second dimerization domains either dimerize spontaneously or in the presence of a chemical inducer of dimerization (page 12 and Fig. 3), wherein the exodomain is an antigen binding domain selected from scFv or binding domain of a natural receptor (abstract and page 23, lines 1-21). PD-L1 binding exodomain would be a PD-1 ectodomain.
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 chimeric cytokine receptor of the copending application to comprise a STAT-recruiting domain of IL2Rb in view of Pule. 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 that the STAT-recruiting domain is from IL2RG and Pule teaches chimeric cytokine receptor comprises either IL-2 receptor beta chain/or IL-2 receptor gamma chain.
Conclusion
14. No claims are allowed.
15. 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 1643
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