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 .
Response to Amendment and Argument
2. Claims 50-63 are pending.
Claims 50, 51, 62 and 63, drawn to non-elected inventions and non-elected species are withdrawn from examination.
Claims 52-57, 59, 61 and 62 have been amended.
Claims 52-61 are examined on the merits with species, (cancer): lung cancer and (detected molecule): b. protein.
3. The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Withdrawn Objections
Drawings
4. The drawings are no longer objected to as the recent submission of the figure caption complies with 37 CFR 1.84(p)(5) including the reference character(s) now mentioned in the description: 11a, see page 9, section 0026, see Amendments to the Specification.
Claim Objections
5. Claims 52 and 53 are no longer objected to because of the listed informalities cited in the first action on the merits (FAOM) mailed July 28, 2025 on page 4, segment 5.
New Grounds of Objection
Specification
6. The disclosure is objected to because of the following informality: it references Figure caption 11a as paragraph 0001, which would replace the cross-reference to related applications information on page 1.
Correction is required.
Withdrawn Grounds of Rejection
Claim Rejections - 35 USC § 112
7. The rejection of claims 52-61 under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for a method for identifying and detecting murine follicular regulatory T cells (TFR) cells expressing the signature CD3+CD4+FOXP3+BCL6+ T cells set in tumor samples from two syngeneic tumor models systems (B16F10 melanoma and MC38 colorectal tumor cells lines), does not reasonably provide enablement for a method for detecting TFR in a subject’s biological sample from lung cancer tissue comprising detecting the presence or increased level of TFR cells with antibodies that are able to detect CD3+CD4+FOXP3+BCL6+ T cells, CD3+CD4+CXCR5+GITR+ T cells or a combination of sets of T cells and furthermore, CD3+CD4+CXCR5+FOXP3+ BCL6+ T cells, CD3+CD4+CXCR5+FOXP3+ T cells, CD3+CD4+CXCR5+ BCL6+ GITR+ T cells, or a combination of sets of T cells and comparing the respective set(s) to a healthy subject and/or reference level generated for a specific type and subsequent treatment is withdrawn in light of Applicant’s arguments and evidence pointed out therein, see paragraph bridging pages 11 and 12 of the Remarks/Arguments submitted January 28, 2026.
8. The rejection of claims 54-59 and 61 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 is withdrawn.
9. Claim 54 no longer recites the limitation "the selective TFR cell depleting therapy" spanning lines 14 and 15, see Amendments to the Claims/ Listing of Claims submitted January 28, 2026.
Claim Rejections - 35 USC § 101
10. The claimed invention (claims 52-61) is no longer directed to non-statutory subject matter in light of the amendment to independent claim 52, see Amendments to the Claims/ Listing of Claims submitted January 28, 2026.
New and Maintained Grounds of Rejection
Claim Rejections - 35 USC § 112
11. Claim 54 recites the limitation "the patient" in line 3. There is insufficient antecedent basis for this limitation in the claim.
12. Claim 55 recites the limitation "the selective TFR cell depleting therapy" in line 4, step (iii). There is insufficient antecedent basis for this limitation in the claim.
13. Claim 59 recites the limitation “the selective depletion of TFR cells” in step (iv) of the claim. It no longer recites "the selective elimination of TFR cells…". There is insufficient antecedent basis for this limitation in the claim.
14. Claim 61 has been amended to now recite the limitation “the selective depletion of TFR cells” in step (iv) of the claim. It no longer recites "the selective elimination of TFR cells…". There is insufficient antecedent basis for this limitation in the claim.
Double Patenting
15. 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.
16. Claims 52-61 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 5-9, 12, 13, 16, 17, 30, 32, 55, 58, 65, 68 and 71 of copending Application No. 18/564,913 (filed November 28, 2023). Although the claims at issue are not identical, they are not patentably distinct from each other because both sets of claims read on assaying a patient’s sample to assess TFR with a biosignature,
CD3+CD4+FOXP3+BCL6+, CD3+CD4+CXCR5+GITR+, or both assaying differences in levels of the biosignature(s) between a patient sample and a healthy subject sample and administering an agent that selectively depletes TFR
cells to the patient.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Allowable Subject Matter
17. The following is a statement of reasons for the indication of allowable subject matter: there seems to be no prior art teaching detecting a method of eliminating T follicular regulatory (TFR) cells with an expressed marker signature, CD3+CD4+FOXP3+BCL6+; CD3+CD4+CXCR5+GITR+; or both on cancer cells that are present or increased in comparison to cells from a healthy subject with subsequent administration of an agent that selectively depletes the TFR cells in the patient, wherein in the agent is at least one of anti-IL1R2, anti-CTLA-4, anti-4-1BB, anti-ICOS, anti-GITR, anti-OX40, or anti-CCR8 prior to July 11, 2019.
Conclusion
18. The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
- Salvatore, B., UCLA Electronic Theses and Dissertations, Follicular Regulatory T cells and Follicular Helper T Cells: Role in HIV Pathogenesis, 45 pages (2018).
19. Any inquiry concerning this communication or earlier communications from the Examiner should be directed to ALANA HARRIS DENT whose telephone number is (571)272-0831. The Examiner works a flexible schedule, however she can generally be reached 8AM-8PM, Monday through Friday.
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, Julie Wu can be reached on 571-272-5205. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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ALANA HARRIS DENT
Primary Examiner
Art Unit 1643
22 April 2026
/Alana Harris Dent/Primary Examiner, Art Unit 1643
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