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 .
Any objection or rejection from the previous office action, which is not restated here, is withdrawn.
Status of Claims
Claims 1-94 were originally filed on January 31, 2022.
The amendment received on December 23, 2022, canceled claims 2-6, 8-10, 12, 16-19, 23-44, 47-56, 58, 60-62, 64-74, 76-77, 80-83, and 86-93; and amended claims 1, 7, 11, 13, 15, 20-22, 45, 57, 59, 63, 75, 78-79, 84-85, and 94. The amendment received on May 7, 2025, canceled claims 11, 13-15, 20-22, 46, 75, 78; and amended claims 1, 7, 45, 59, 63, and 84. The amendment received on November 24, 2025, canceled claim 7; and amended claims 1, 45, and 84-85.
Claims 1, 45, 57, 59, 63, 79, 84-85, and 94 are currently pending and under consideration.
Priority
The present application claims status as a 371 (National Stage) of PCT/IB2020/057174 filed July 29, 2020, and claims priority under 119(e) to U.S. Provisional Application Nos. 62/880,509 filed on July 30, 2019, and 63/029,115 filed on May 22, 2020.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on November 24, 2025 is being considered by the examiner.
Sequence Interpretation
For claim 1, please note that the Examiner is interpreting the scope as open-ended requiring 100% identity to SEQ ID NO: 3 with any N- and/or C-terminal additions.
For claim 45, please note that the Examiner is interpreting the scope as open-ended requiring 100% identity to SEQ ID NO: 4 with any N- and/or C-terminal additions. It is noted that SEQ ID NO: 4 contains SEQ ID NO: 3 but with an additional 17 residues at the N-terminus.
Response to Arguments
Applicant’s arguments, see Response, filed 11/24/25, with respect to the specification objection have been fully considered and are persuasive. The objection to the specification has been withdrawn.
Applicant’s arguments, see Response, filed 11/24/25, with respect to the claim objection have been fully considered and are persuasive. The objection to claim 85 has been withdrawn.
Applicant’s arguments, see Response, filed 11/24/25, with respect to the 112(a), written description, rejection have been fully considered and are persuasive. The rejections of claims 1, 7, 13, 57, 59, 63, 79, 84-85, and 94 as failing to comply with the written description requirement has been withdrawn.
Applicant’s arguments, see Response, filed 11/24/25, with respect to the 112(a), scope of enablement, rejection have been fully considered and are persuasive. The rejection of claims 84-85 as failing to comply with the enablement requirement has been withdrawn.
New Objections
Claim Objections
Claim 1 is objected to because of the following informalities: claim 1 recites, “[a]n HLA class II molecule…” Although, the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). The Examiner respectfully requests that Applicant uses human leukocyte antigen (HLA) class II molecule for the first recitation, thereafter HLA class II molecule may be utilized. Appropriate correction is required.
Maintained/Modified Rejections in light of Applicants’ Arguments
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, 13, 57, 59, 63, 79, and 84 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2, 6-7, 48, 53-55, 80, 83, 89, 93, and 98 of copending Application No. 17/631,818 (US 20220291215 A1). Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the ‘818 application render obvious the instant claims by utilizing an obvious-to-try rationale at minimum. Please note that claim 45 has been removed from the rejection in light of the amendments to the claim. In particular, the ‘818 claimed invention does not encompass 100% identity to instant SEQ ID NO: 4.
In particular, the ‘818 application claims a method of using a T cell with a complex comprising an MHC class II molecule (note: necessarily constituting a cell comprising the HLA class II molecule), wherein the MHC class II molecule comprises a beta chain comprising the same amino acid sequences recited in the instant claims, and wherein the method encompasses the MHC class II molecule being expressed on the surface of an APC and has an affinity for CD4 higher than that of a natural MHC class II molecule thereby constituting the instant method of claim 84. See especially claims 48, 53, 54, and 55 of the ‘818 application where the HLA class II molecule comprises the instant substitutions at the instant positions as recited in claims 1 and 7 and where ‘818 SEQ ID NO: 19 is 100% to instant SEQ ID NO: 3 when the substitutions are made. Claims drawn to a method of using a polypeptide render obvious claims drawn to the polypeptide per se. Therefore, an ordinary skilled artisan would be motivated, at a minimum, to try to substitute the residues at positions 114, 118, 143, and 157 as instantly claimed given the finite number of possible combinations in ‘818 claim 54 with a reasonable expectation of success.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Applicants’ Arguments
Applicants respectfully request that the present double-patenting rejection be held in abeyance until otherwise patentably subject matter is identified (See Applicants Response received on 12/24/25, pg. 8).
Response to Arguments
Applicant’s request to hold the present double-patenting rejection be held in abeyance until otherwise patentably subject matter is identified is acknowledged. As such, the double-patenting rejection is maintained.
Conclusion
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to THEA D' AMBROSIO whose telephone number is (571)270-1216. The examiner can normally be reached M-F 11:00 to 8:00 pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Lianko Garyu can be reached at 571-270-7367. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/THEA D' AMBROSIO/Primary Examiner, Art Unit 1654