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 .
Status of the Claims
Claims 1-14 were originally filed May 13, 2022.
The amendment received June 13, 2022 amended claim 1.
The amendment received May 14, 2025 amended claim 1.
The amendment received December 1, 2025 amended claims 1, 3-9, and 13 and cancelled claims 2.
Claims 1 and 3-14 are currently pending.
Claims 1 and 3-9 are currently under examination.
Election/Restrictions
Applicants elected, without traverse, Group I (claims 1-9) in the reply filed on May 14, 2025. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Claims 10-14 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to nonelected methods, there being no allowable generic or linking claim.
Applicants elected, without traverse, a nucleic acid that encodes a CDR3 of an a and b chain of a TCR which binds SEQ ID NO: 26, a lentivirus, a CD8+ T cell, and a pharmaceutically acceptable excipient as the species in the reply filed on May 14, 2025. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Please note: the election of a nucleic acid that encodes a CDR3 of an a and b chain of a TCR which binds SEQ ID NO: 26 is not a single, specific species. While present claim 3 could be withdrawn due to the elected species not necessarily reading on the elected genus, claim 3 has been examined in order for compact prosecution to occur. The examiner of record has chosen species to search (see below; i.e. not all species in present claim 3 were searched). See MPEP § 803.02.
Potential Rejoinder
Applicant elected claims directed to a product. If a product claim is subsequently found allowable, withdrawn process claims that depend from or otherwise include all the limitations of the allowable product claim will be rejoined in accordance with the provisions of MPEP § 821.04. Process claims that depend from or otherwise include all the limitations of the patentable product will be entered as a matter of right if the amendment is presented prior to final rejection or allowance, whichever is earlier. Amendments submitted after final rejection are governed by 37 CFR 1.116; amendments submitted after allowance are governed by 37 CFR 1.312.
In the event of rejoinder, the requirement for restriction between the product claims and the rejoined process claims will be withdrawn, and the rejoined process claims will be fully examined for patentability in accordance with 37 CFR 1.104. Thus, to be allowable, the rejoined claims must meet all the criteria for patentability including the requirements of 35 U.S.C. 101, 102, 103, and 112. Until an elected product claim is found allowable, an otherwise proper restriction requirement between product claims and process claims may be maintained. Withdrawn process claims that are not commensurate in scope with an allowed product claim will not be rejoined. See “Guidance on Treatment of Product and Process Claims in light of In re Ochiai, In re Brouwer and 35 U.S.C. § 103(b),” 1184 O.G. 86 (March 26, 1996). Additionally, in order to retain the right to rejoinder in accordance with the above policy, applicant is advised that the process claims should be amended during prosecution either to maintain dependency on the product claims or to otherwise include the limitations of the product claims. Failure to do so may result in a loss of the right to a rejoinder. Further, note that the prohibition against double patenting rejections of 35 U.S.C. 121 does not apply where the restriction requirement is withdrawn by the examiner before the patent issues. See MPEP § 804.01.
Priority
The present application is a CIP of 16/627,230 filed December 27, 2019 (now U.S. Patent 11,352,389) which is a 371 (National Stage) of PCT/NL2018/050421 filed June 28, 2018 which claims foreign priority to Netherlands 2020602 filed March 16, 2018 and Netherlands 2019156 filed June 30, 2017.
Present claim 3 has a priority date of the filing date of the present application (May 13, 2022). Parent application 16/627,230 only disclosed 34 sequences (SEQ ID NOs: 1-34). Therefore, the sequences in claim 3 do not have priority to the parent application 16/627,230.
Specification
The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code. 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. See page 92, line 37 and page 93, lines 4 and 27.
Please note: simply deleting http:// does not negate the hyperlink. Applicants may refer to the website (e.g. the gcg website).
The lengthy specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the specification.
Claim Objections
Claim 6 is objected to because of the following informalities: synthetic DNA or synthetic RNA are not considered vectors per se given the definitions in the art. Appropriate correction is required.
Please note: the claim was not amended to correct the issues with synthetic DNA or synthetic RNA. The definition of vector in the specification does not negate the issues. Synthetic DNA or synthetic RNA may broaden the scope of the presently claimed vector.
Sequence Interpretation
The Office interprets claims comprising SEQ ID NOs: in the following manner: “comprising a sequence of SEQ ID NO: 1” requires only a 2mer of SEQ ID NO: 1, “comprising the sequence of SEQ ID NO: 1” requires the full-length sequence with 100% identity to SEQ ID NO: 1 with any N-/C-terminal additions or any 5’/3’ additions, “consisting of SEQ ID NO: 1” requires the full-length sequence with 100% identity to SEQ ID NO: 1 and the same length as SEQ ID NO: 1, and “selected from the group consisting of SEQ ID NOs: 1, 2, and 3” requires the full-length sequence with 100% identity to SEQ ID NOs: 1, 2, or 3 and the same length as SEQ ID NOs: 1, 2, or 3. Any claim requiring a specific sequence identity to a SEQ ID NO:, requires the recited, specific sequence identity to the specific SEQ ID NO:.
New Rejections Necessitated by Amendment
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.
Claim 6 is 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. One of ordinary skill in the art would not be able to determine the scope of the present claim. For example, it is unclear how “synthetic DNA” and “synthetic RNA” are to be construed as a “plasmid” or a “viral vector” based on the definition in the art.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1, 3, 4, and 6-9 are rejected under 35 U.S.C. 101 because the claimed invention is directed to naturally occurring TCR without significantly more. The claims recite polynucleotides encoding naturally occurring TCRs (see pages 3-5). This judicial exception is not integrated into a practical application because the present claims are drawn to the polynucleotides encoding TCRs only. The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the synthetic DNA or synthetic RNA and cells (i.e. T cells expressing TCRs) are naturally occurring.
Claim Rejections - 35 USC § 102
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)(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.
Claims 1 and 4-9 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Fritsch et al. WO 2016/187508 published November 24, 2016.
For present claims 1 and 4-9, Fritsch et al. teach SEQ ID NOs: 20415 and 20418 (AVEEVSLRK) and polynucleotides encoding TCRs which bind SEQ ID NOs: 20415 and 20418 (AVEEVSLRK), vectors including plasmids and viral vectors for expressing the TCRs, and cells including CD8 T cells comprising the vectors and carriers (please refer to the entire specification particularly paragraphs 35, 121, 123, 124, 134-171, 319-330, 369-382; claims 130-131, 139-149, 171-191, etc.).
Therefore, the present polynucleotides are anticipated by the teachings of Fritsch et al.
Arguments and Response
Applicants’ arguments directed to the rejection under 35 USC 102 (a)(1) as being anticipated by Fritsch et al. for claims 1 and 4-9 were considered but are not persuasive for the following reasons.
Applicants contend that the amendments received December 1, 2025 negate the rejection.
Applicants’ arguments are not convincing since the teachings of Fritsch et al. anticipate the polynucleotides of the instant claims. The present specification at pages 3-5 state that TCRs specific for SEQ ID NO: 26 bind to HLA-A-A*11:01, HLA-A*03:01, or HLA-A*01:01. Therefore, polynucleotides encoding the same TCR would have the same functions.
"Products of identical chemical composition can not have mutually exclusive properties." See In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present. Id. (Applicant argued that the claimed composition was a pressure sensitive adhesive containing a tacky polymer while the product of the reference was hard and abrasion resistant. "The Board correctly found that the virtual identity of monomers and procedures sufficed to support a prima facie case of unpatentability of Spada’s polymer latexes for lack of novelty.").
Claims 1 and 4-9 are rejected under pre-AIA 35 U.S.C. 102(a)(1) as being anticipated by Sahin et al. WO 2012/038055 published March 29, 2012.
For present claims 1 and 4-9, Sahin et al. teach polynucleotides encoding present SEQ ID NO: 53 (see SEQ ID NOs: 98, 142 – at least 90% identical) as a CDR3 in TCRs; vectors comprising the polynucleotides wherein the vectors are plasmids, viral vectors, adenoviral vectors, etc.; host cells comprising the vectors wherein the host cells are CD8 T cells, CD4 T cells, stem cells, etc.; and carriers, adjuvants, diluents, etc. (please refer to the entire specification particularly the abstract; pages 1-5, 7-16, 34-38, 45, 58, 59, 69-72, 103, 112; claims).
Therefore, the present polynucleotides are anticipated by the teachings of Sahin et al.
Arguments and Response
Applicants’ arguments directed to the rejection under 35 USC 102 (a)(1) as being anticipated by Sahin et al. for claims 1 and 4-9 were considered but are not persuasive for the following reasons.
Applicants contend that the amendments received December 1, 2025 negate the rejection.
Applicants’ arguments are not convincing since the teachings of Sahin et al. anticipate the polynucleotides of the instant claims. The present specification at pages 3-5 state that TCRs specific for SEQ ID NO: 26 bind to HLA-A-A*11:01, HLA-A*03:01, or HLA-A*01:01. Therefore, polynucleotides encoding the same TCR would have the same functions.
"Products of identical chemical composition can not have mutually exclusive properties." See In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present. Id. (Applicant argued that the claimed composition was a pressure sensitive adhesive containing a tacky polymer while the product of the reference was hard and abrasion resistant. "The Board correctly found that the virtual identity of monomers and procedures sufficed to support a prima facie case of unpatentability of Spada’s polymer latexes for lack of novelty.").
Claims 1 and 4-9 are rejected under pre-AIA 35 U.S.C. 102(a)(1) as being anticipated by Gros et al. WO 2016/179006 published November 10, 2016.
For present claims 1 and 4-9, Gros et al. teach polynucleotides encoding present SEQ ID NO: 69 (see SEQ ID NOs: 43, 59 – at least 90% identical) as a CDR3 in TCRs; vectors comprising the polynucleotides wherein the vectors are plasmids or viral vectors including retroviral vectors, etc.; host cells comprising the vectors wherein the host cells are CD8 T cells, CD4 T cells, etc.; and carriers, etc. (please refer to the entire specification particularly the abstract; paragraphs 3-5, 14-17, 23, 24, 41-55, 62-65, 69, 72, 74, 77, 79, 88-90, 95-102; claims).
Therefore, the present polynucleotides are anticipated by the teachings of Gros et al.
Arguments and Response
Applicants’ arguments directed to the rejection under 35 USC 102 (a)(1) as being anticipated by Gros et al. for claims 1 and 4-9 were considered but are not persuasive for the following reasons.
Applicants contend that the amendments received December 1, 2025 negate the rejection.
Applicants’ arguments are not convincing since the teachings of Gros et al. anticipate the polynucleotides of the instant claims. The present specification at pages 3-5 state that TCRs specific for SEQ ID NO: 26 bind to HLA-A-A*11:01, HLA-A*03:01, or HLA-A*01:01. Therefore, polynucleotides encoding the same TCR would have the same functions.
"Products of identical chemical composition can not have mutually exclusive properties." See In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present. Id. (Applicant argued that the claimed composition was a pressure sensitive adhesive containing a tacky polymer while the product of the reference was hard and abrasion resistant. "The Board correctly found that the virtual identity of monomers and procedures sufficed to support a prima facie case of unpatentability of Spada’s polymer latexes for lack of novelty.").
Double Patenting
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.
Claims 1 and 3-9 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-11, 15, and 16 of copending Application No. 18/865,485 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because both the present claims and the claims of copending Application No. 18/865,485 (reference application) are drawn to polynucleotides encoding a CDR3 of a TCR a and/or b chain that specifically binds AVEEVSLRK, vectors including plasmids and viral vectors containing the polynucleotides, and cells comprising the vectors and carriers, etc.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Arguments and Response
Applicants’ arguments directed to the rejection on the ground of nonstatutory obviousness-type double patenting as being unpatentable over copending Application No. 18/865,485 (reference application) for claims 1 and 3-9 were considered but are not persuasive for the following reasons.
Applicants state that they will consider filing a TD and request that the rejection be held in abeyance.
Applicants’ arguments are not convincing since the claimed invention of copending Application No. 18/865,485 (reference application) renders obvious the polynucleotides of the instant claims. In addition, while a request may be made that objections or requirements as to form not necessary to further consideration of the claims be held in abeyance until allowable subject matter is indicated, the present is a rejection and will not be held in abeyance (see MPEP § 714.02).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
AVEEVSLRK:
WO 2015/017863
Verhaak et al., 2005, Mutations in nucleophosmin (NPM1) in acute myeloid leukemia (AML): association with other gene abnormalities and previously established gene expression signatures and their favorable prognostic significance, Blood, 106(12): 3747-3754.
Falini et al., 2005, Cytoplasmic Nucleophosmin in Acute Myelogenous Leukemia with a Normal Karyotype, The New England Journal of Medicine, 352(3): 254-266.
WO 2006/046270 (SEQ ID NOs: 30-33 contain AVEEVSLRK; CLAVEEVSLRK also disclosed)
U.S. Patent Application Publications 20080299560; 20090297543; 20150184245; and 20150368726
U.S. Patents 8,222,370 and 8,501,924
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Future Communications
Any inquiry concerning this communication or earlier communications from the examiner should be directed to AMBER D STEELE whose telephone number is (571)272-5538. The examiner can normally be reached M-F 8-5.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Melissa Fisher can be reached at 571-270-7430. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/AMBER D STEELE/Primary Examiner, Art Unit 1658