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
Election/Restrictions
1. Applicant's species election filed December 16, 2025 is acknowledged and has been entered. Applicant elected Species A: cytotoxic T cells and M1 macrophages in claim 2; Species B: an antibody in claim 8; and Species C: colorectal cancer in claim 9. Election of Species A, Species B, and Species C read on claims 1-3 and 8-12. Upon further consideration, Species A: TILs of claim 5 has been rejoined for prosecution on the merits. 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 Claims 4, 6, and 7 are withdrawn from further consideration by the examiner, 37 CFR 1.142(b), as being claims drawn to a non-elected species. Accordingly, claims 1-12 are pending. Claims 1-3, 5, and 8-12 are under examination.
Priority
2. Receipt is acknowledged of certified copies of foreign priority papers required by 37 CFR 1.55, which papers have been placed of record in the file.
3. Acknowledgment is made of Applicant’s claim for foreign priority under 35 U.S.C. 119 (a)-(d) or (f), 365(a) or (b) or 386(a) on the basis of the filing dates of REPUBLIC OF KOREA 10-2021-0124736 filed 09/17/2021, REPUBLIC OF KOREA 10-2022-0092787 filed 07/26/2022, REPUBLIC OF KOREA 10-2022-0095105 filed 07/29/2022, REPUBLIC OF KOREA 10-2022-0096407 filed 08/02/2022, and REPUBLIC OF KOREA 10-2022-0099498 filed 09/09/2022, Based on the filing receipt, the effective filing date of this National Stage application, which is a 371 of PCT/KR2022/013919 filed 05/16/2022, is September 17, 2021 which is the filing date of Foreign Application REPUBLIC OF KOREA 10-2021-0124736 from which the benefit of foreign priority is claimed.
Abstract
4. Applicant is reminded of the proper language and format for an abstract of the disclosure.
The abstract should be in narrative form and generally limited to a single paragraph on a separate sheet within the range of 50 to 150 words in length. The abstract should describe the disclosure sufficiently to assist readers in deciding whether there is a need for consulting the full patent text for details.
The language should be clear and concise and should not repeat information given in the title. It should avoid using phrases which can be implied, such as, “The disclosure concerns,” “The disclosure defined by this invention,” “The disclosure describes,” etc. In addition, the form and legal phraseology often used in patent claims, such as “means” and “said,” should be avoided.
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.
5. Claims 1-3, 5, and 8-12 are 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.
Claim 1, step c) in line 2 lacks antecedent basis in reciting “the group.” Does Applicant intend “the mixture?” Same analogous comment and problem causing ambiguity apply to the recitations of “a positive control group” or “a group not treated with the anticancer drug candidate.”
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.
6. Claims 1, 2, and 8-12 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1, 2, 7-9, and 16-18 of copending Application No.18/563,649 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because both inventions recite a system and method for evaluating an efficacy of an anticancer drug candidate and/or screening an anticancer drug candidate comprising (a) mixing and co-culturing cancer organoids with immune cells such as TILs; (b) treating the mixture of step (a) with an anticancer antibody drug candidate; and (c) determining that the efficacy of the anticancer drug candidate is excellent when a growth inhibition or death of cancer organoid is increased compared to a positive control group or a group not treated with the anticancer drug candidate.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
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.
7. Claims 11 and 12 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by
LI et al. (Co-culture of tumor organoids with immune cells for immune-oncology drug development. Mol Cancer Ther 18 (12 Supplement): B142 (2019)).
LI et al. disclose an anticancer drug screening system and/or anticancer drug efficacy evaluation system (Hubrecht organoid technology (HUB) comprising cancer (tumor) organoids and immune cells or tumor infiltrating lymphocytes (TILs) for applications in discovery drug discovery. See entire Abstract.
8. Claims 11 and 12 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Cattaneo et al. (Tumor organoid-T-cell coculture systems. Nature Protocols 15: 15-39 (January 2020)).
Cattaneo et al. disclose an ex vivo anticancer drug screening test system and/or anticancer drug efficacy evaluation test system comprising cancer (tumor) organoids and immune cells or peripheral blood lymphocytes for applications in T-cell-based immunotherapy (Abstract; pp. 15-17).
9. Claims 1, 2, 5, and 6-10 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Appleton et al. (US 2023/0042929 A1).
Appleton et al. disclose a method for evaluating an efficacy of an anticancer drug candidate and/or screening an anticancer drug candidate (therapeutic agents) for treating cancer including colorectal cancer by measuring responsiveness of tumor cells to the anticancer drug candidate (Abstract; 0091). The method comprises (a) mixing cancer organoids (spheroids) and immune cells at a ratio of 1 : 0.5 to 5 and co-culturing the mixture [0099, 0111, 0112]; (b) treating the mixture of step (a) with an anticancer drug candidate (Example 5); and (c) determining that the efficacy of the anticancer drug candidate is excellent when growth inhibition or death of cancer organoid (spheroid death) is increased treated with the anticancer drug candidate of step (b) compared to a positive control or untreated coculture mixture ([0040, 0100]; Example 5; Claim 1). Appleton et al. show using cytotoxic T cells or tumor infiltrating lymphocytes (TILs) as immune cells used in the method (Example 1, Example 5). Appleton et al. teach that the cancer organoid and TIL cell as immune cell number ratio may be 1 : 1 to 2 ([0111, 0112]; Example 5). Appleton et al. teach that the anticancer drug candidate is monoclonal antibody pembrolizumab (Example 5).
9. Claim 3 is free of the prior art of record.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to GAILENE R. GABEL whose telephone number is (571)272-0820. The examiner can normally be reached Monday, Tuesday, and Thursday 5:30 AM to 4:00 PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Gregory S. Emch can be reached at (571) 272-8149. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/GAILENE GABEL/Primary Examiner, Art Unit 1678
February 20, 2026