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 .
DETAILED ACTION
Applicant’s election with traverse of Group II, claims 9-17 and 19, in the reply filed on 05/26/2026 is acknowledged. The traversal is on the ground(s) that the search and examination of all the Groups would not impose an undue burden. This is not found persuasive, because the Groups from the Requirement for Restriction/Election, dated 03/26/2026, are independent or distinct, as indicated at p. 4 and 5 of the Requirement. Furthermore as indicated at p. 5 of the Requirement, there would be a serious search and/or examination burden if restriction were not required, at least because the Groups require a different field of search (e.g., searching different classes/subclasses or electronic resources, or employing different search strategies or search queries).
The requirement is still deemed proper and is therefore made FINAL.
Claims 1-20 are pending.
Claims 1-8, 18, and 20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 05/26/2026.
Claims 9-17 and 19 are under examination on the merits.
Priority
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. Claims 9-17 and 19 have an effective filing date of 05/01/2015, corresponding to PRO 62/155,761.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 06/05/2023 and 06/24/2025 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
Notes on the Prior Art
Following a prior art search, it is submitted that the prior art does not teach or suggest an isolated nucleic acid molecule encoding an immunotherapeutic molecule comprising a tumor-associated carbohydrate antigen (TACA)-binding domain derived from a lectin; wherein the immunotherapeutic molecule is: (i) a fusion protein comprising a tumor-associated carbohydrate antigen (TACA)-binding domain derived from a lectin and a domain that specifically binds to an immune effector cell; or (ii) a chimeric antigen receptor (CAR) comprising an antigen recognition domain that comprises the TACA-binding domain derived from a lectin, a transmembrane domain, and an intracellular signaling domain; wherein the TACA-binding domain specifically binds to a TACA of a tumor cell; and wherein the lectin is selected from those recited in claim 9.
Claim Rejections
Nonstatutory 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 9-17 and 19 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-9 of U.S. Patent No. 10,925,972.
Although the claims at issue are not identical, they are not patentably distinct from each other, because both sets of claims encompass a composition comprising an isolated nucleic acid molecule encoding a peptide, wherein the peptide comprises a TACA-binding domain derived from a lectin, and an immune cell recognition domain that specifically binds to a receptor on an immune effector cell, wherein the TACA-binding domain specifically binds to a TACA of a tumor cell, wherein: the lectin is selected from the group consisting of a galectin, a siglec, etc. The conflicting claims also encompass the same galectins, siglecs, TACA-binding domains, and T cell binding domains.
Claims 9-17 and 19 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of copending Application No. 19/682,022 (reference application).
Although the claims at issue are not identical, they are not patentably distinct from each other, because both sets of claims encompass a composition comprising an isolated nucleic acid molecule encoding a peptide, wherein the peptide comprises a TACA-binding domain derived from a lectin, and an immune cell recognition domain that specifically binds to a receptor on an immune effector cell, wherein the TACA-binding domain specifically binds to a TACA of a tumor cell, wherein: the lectin is selected from the group consisting of a galectin, a siglec, etc. The conflicting claims also encompass the same galectins, siglecs, TACA-binding domains, and T cell binding domains, i.e., domains that bind to surface antigens CD3, CD4, and CD8.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NELSON B MOSELEY II whose telephone number is (571)272-6221. The examiner can normally be reached on M-F, 9:00-6:00 EST.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Samira Jean-Louis, can be reached at 571-270-3503. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/NELSON B MOSELEY II/Primary Examiner, Art Unit 1642
Prosecution Insights