Prosecution Insights
Last updated: October 02, 2026
Application No. 18/035,280

CAR T CELL THERAPY IN PATIENTS WHO HAVE HAD PRIOR ANTI-CANCER ALKYLATOR THERAPY

Final Rejection §112§DOUBLEPATENT
Filed
May 03, 2023
Priority
Nov 04, 2020 — provisional 63/109,804 +3 more
Examiner
CHANDRAKUMAR, NIZAL S
Art Unit
1625
Tech Center
1600 — Biotechnology & Organic Chemistry
Assignee
Bms
OA Round
2 (Final)
73%
Grant Probability
Favorable
3-4
OA Rounds
0m
Est. Remaining
91%
With Interview

Examiner Intelligence

Grants 73% — above average
73%
Career Allowance Rate
1298 granted / 1785 resolved
+12.7% vs TC avg
Strong +18% interview lift
Without
With
+18.3%
Interview Lift
resolved cases with interview
Typical timeline
2y 3m
Avg Prosecution
81 currently pending
Career history
1869
Total Applications
across all art units

Statute-Specific Performance

§101
2.1%
-37.9% vs TC avg
§103
29.2%
-10.8% vs TC avg
§102
10.9%
-29.1% vs TC avg
§112
36.9%
-3.1% vs TC avg
Black line = Tech Center average estimate • Based on career data from 1785 resolved cases

Office Action

§112 §DOUBLEPATENT
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 . Amended claims 13-21, 23, 87, 92, 94, 127, 128-130, 132-134 are examined. Claims 6-8, 51-53, 131, 96, 98, 97, 99, 123, 125, 126 remain withdrawn. Applicants persuasive arguments overcome the previously presented obviousness rejection. This action takes into consideration discussions with Attorney regarding scope of the claims and informal communication by authorized email of amended claims. 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. Claims 13-21, 23, 87, 92, 94, 127, 128-130, 132-134 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. The terms ‘at least about’ render the base claim indefinite as the boundaries (upper limit) of the essential subject unclear. This relates to subject matter that is an essential element which allegedly differentiates the claimed subject matter novel, because, as argued in Remarks filed 08/06/2026, “Claim 13, and claims dependent thereon, are directed to this optimal washout period of at least about six months, a threshold that was neither known nor predictable from the prior art” Dependent claims do not solve the problem of the base claim. As such claims 14-21, 23, 87, 92, 94, 127, 128-130, 132-134 are rejected as well. 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. Claim(s) 13-21, 23 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 14 of copending Application No. 18864469 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the conflicting claim contains overlapping subject matter. 18864469: 14. (Currently Amended) A method of treating a tumor or a cancer in a subject in need thereof, comprising administering to a subject T cells manufactured from peripheral blood mononuclear cells (PBMCs) isolated from the patient subject, wherein: the subject has been administered a prior therapy selected from a topoisomerase inhibitor therapy or a proteasome inhibitor therapy; and at the time the PBMCs are isolated, the subject has last received the prior therapy at least about six (6) months prior to the time the PBMCs are isolated. Instant Base claim 13: 13: A method of treating a tumor or a cancer in a subject in need thereof, wherein the subject has been administered an alkylating agent, comprising administering to the subject T cells expressing a chimeric antigen receptor (CAR T cells) manufactured from a sample comprising peripheral blood mononuclear cells PBMCs isolated from the subject, wherein at the time the PBMCs are isolated, the subject has last received the alkylating agent at least about six (6) months prior to the time the PBMCs are isolated. The difference is the prior chemotherapy in the conflicting claim. The method is same in both cases and administered agent in the treatment method in both cases is the same: Chimeric Antigen Receptor (CAR) T-cell therapy, a personalized immunotherapy that genetically modifies a patient's own T-cells to detect and destroy cancer cells, primarily treating relapsed or refractory blood cancers like leukemia, lymphoma, and myeloma. For example, topoisomerase inhibitors are key agents in multiple myeloma (MM) treatment, targeting enzymes responsible for DNA replication and repair. This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented. Claim Rejections - 35 USC § 112 The following is a quotation of the first paragraph of 35 U.S.C. 112(a): (a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention. The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112: The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention. Claims 13-21, 23, 87, 92, 94, 127, 128-130, 132-134 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for some forms of myelomas and lymphomas, is not enabling for treating any and all tumors or cancers. Similarly, that disclosure with respect to alkylating agents, washout period (more later), and when the treatment was initiated are limited. The specification lacks disclosure on how to make and use, in predictable manner, the full scope of the claimed invention without undue experimentation. The determination that "undue experimentation" would have been needed to make and use the claimed invention is not a single, simple factual determination. Rather, it is a conclusion reached by weighing all the relevant factual considerations. Enablement is considered in view of the Wands factors (MPEP 2164.01 (a)). These include: (1) breadth of the claims; (2) nature of the invention; (3) state of the prior art; (4) amount of direction provided by the inventor; (5) the level of predictability in the art; (6) the existence of working examples; (7) quantity of experimentation needed to make or use the invention based on the content of the disclosure; and (8) relative skill in the art. All the factors have been considered with regard to the claims, with the most relevant factors discussed below: The instant base claim 13 is directed to ‘a method for treatment of tumor or cancer. This assertion is contrary to what is known in medicine, proof must be provided that this revolutionary assertion has merits. The existence of such a “silver bullet” is contrary to our present understanding of oncology. The state of the art is not indicative that any pharmaceutical agents that are useful in the treatment of cancer generally. Different types of cancers affect different organs and have different methods of growth and harm to the body. Also see In re Buting, 163 USPQ 689 (CCPA 1969), wherein 'evidence involving a single compound and two types of cancer, was held insufficient to establish the utility of the claims directed to disparate types of cancers'. Thus, it is beyond the skill of oncologists today to get an agent to be effective against cancers generally. A similar statement appears at In re Application of Hozumi et al., 226 USPQ 353: “In spite of the vast expenditure of human and capital resources in recent years, no one drug has been found which is effective in treating all types of cancer. Cancer is not a simple disease, nor is it even a single disease, but a complex of a multitude of different entities, each behaving in a different way”. There are compounds that treat a modest range of cancers, but no one has ever been able to figure out how to get a compound to be effective against cancer generally, or even a majority of cancers. Attempts to find compounds to treat the various cancers arguably constitute the single most massive enterprise in all of pharmacology. This has not resulted in finding any treatment for tumors generally. Indeed, the existence of such a "silver bullet" is contrary to our present understanding in oncology. This is because it is now understood that there is no “master switch” for cancers generally; cancers arise from a bewildering variety of differing mechanisms. Even the most broadly effective antitumor agents are only effective against a small fraction of the vast number of different cancers known. This is true in part because cancers arise from a wide variety of sources, primarily a wide variety of failures of the body's cell growth regulatory mechanisms, but also such external factors such as viruses. Accordingly, there is substantive “reason for one skilled in the art to question the objective truth of the statement of utility or its scope” (In re Langer, 183 USPQ 288, 297), specifically, the scope of covering cancer generally. Similarly, In re Novak, 134 USPQ 335, 337-338, says “unless one with ordinary skill in the art would accept those allegations as obviously valid and correct, it is proper for the examiner to ask for evidence which substantiates them.” There is no such evidence in this case. Likewise, In re Cortright, 49 USPQ2d 1464, states: “Moreover, we have not been shown that one of ordinary skill would necessarily conclude from the information expressly disclosed by the written description that the active ingredient” does what the specification surmises that it does. That is exactly the case here. Moreover, even if applicants’ assertion that cancer in general could be treated with these compounds were plausible --- which it is not ---, that “plausible” would not suffice, as was stated in Rasmusson v. SmithKline Beecham Corp., 75 USPQ2d 1297, 1301: “If mere plausibility were the test for enablement under section 112, applicants could obtain patent rights to “inventions” consisting of little more than respectable guesses as to the likelihood of their success.” Applicants have not provided any competent evidence or disclosed tests that are highly predictive for the pharmaceutical use of the instant compounds. Pharmacological activity in general is a very unpredictable area (More on this below). Note that in cases involving physiological activity such as the instant case, “the scope of enablement obviously varies inversely with the degree of unpredictability of the factors involved”. See In re Fisher, 427 F.2d 833, 839, 166 USPQ 18, 24 (CCPA 1970). The treatment of cancer generally cannot possibly be considered enabled. By way of background, four cases are of particular relevance to the question of enablement of a method of treating cancers broadly or even generally are noted below. See later for more on CAR T cell treatment for cancer). In In re Buting, 57 CCPA 777, 418 F.2d 540, 163 USPQ 689, the claim was drawn to “The method of treating a malignant condition selected from the group consisting of leukemias, sarcomas, adenocarcinomas, lymphosarcomas, melanomas, myelomas, and ascitic tumors” using a small genus of compounds. The Court decided that human testing “limited to one compound and two types of cancer” was not “commensurate with the broad scope of utility asserted and claimed”. .In Ex parte Jovanovics, 211 USPQ 907 the claims were drawn to “the treatment of certain specified cancers in humans” by the use of a genus of exactly two compounds, the N-formyl or N-desmethyl derivative of leurosine. Applicants submitted “affidavits, publications and data” for one of the compounds, and a dependent claim drawn to the use of that species was allowed. For the other, no data was presented, applicants said only that the other derivative would be expected to be less effective; claims to the genus were refused. In Ex parte Busse, et al., 1 USPQ2d 1908, claims were drawn to “A therapeutic method for reducing metastasis and neoplastic growth in a mammal” using a single species. The decision notes that such utility “is no longer considered to be “incredible”, but that “the utility in question is sufficiently unusual to justify the examiner's requirement for substantiating evidence. Note also that there is also a dependent claim 5 which specified “wherein metastasis and neoplastic growth is adenocarcinoma, squamous cell carcinoma, melanoma, cell small lung or glioma.” The decision notes that “even within the specific group recited in claim 5 some of the individual terms used actually encompass a relatively broad class of specific types of cancer, which specific types are known to respond quite differently to various modes of therapy.” In Ex parte Stevens, 16 USPQ2d 1379 a claim to “A method for therapeutic or prophylactic treatment of cancer in mammalian hosts” was refused because there was “no actual evidence of the effectiveness of the claimed composition and process in achieving that utility.” Cancer is a broad umbrella term used to describe a collection of more than 100 different diseases. While it is often spoken of as a single condition, it can originate in almost any tissue or organ system of the human body. As such the claimed method is for treating any and all tumor or cancer such as lymphoma, lung cancer, breast cancer, prostate cancer, adrenocortical carcinoma, thyroid carcinoma, nasopharyngeal carcinoma, melanoma, skin carcinoma, colorectal carcinoma, a desmoid tumor, a desmoplastic small round cell tumor, an endocrine tumor, a Ewing sarcoma, a peripheral primitive neuroectodermal tumor, a solid germ cell tumor, a hepatoblastoma, a neuroblastoma, a non-rhabdomyosarcoma soft tissue sarcoma, an osteosarcoma, a retinoblastoma, a rhabdomyosarcoma, a Wilms tumor, a glioblastoma, a myxoma, a fibroma, a lipomachronic lipoma, chronic lymphocytic leukemia (small lymphocytic lymphoma), B-cell prolymphocytic leukemia, lymphoplasmacytic lymphoma, Waldenstrom macroglobulinemia, splenic marginal zone lymphoma, plasma cell myeloma, plasmacytoma, extranodal marginal zone B cell lymphoma, MALT lymphoma, nodal marginal zone B cell lymphoma, follicular lymphoma, mantle cell lymphoma, diffuse large B cell lymphoma, mediastinal (thymic) large B cell lymphoma, intravascular large B cell lymphoma, primary effusion lymphoma, Burkitt's lymphoma, T lymphocyte prolymphocytic leukemia, T lymphocyte large granular lymphocytic leukemia, aggressive NK cell leukemia, adult T lymphocyte leukemia/lymphoma, extranodal NK/T lymphocyte lymphoma, nasal type, enteropathy- type T lymphocyte lymphoma, hepatosplenic T lymphocyte lymphoma, blastic NK cell lymphoma, mycosis fungoides, Sezary syndrome, primary cutaneous anaplastic large cell lymphoma, lymphomatoid papulosis, angioimmunoblastic T lymphocyte lymphoma, peripheral T lymphocyte lymphoma (unspecified), anaplastic large cell lymphoma, Hodgkin lymphoma, a non-Hodgkin lymphoma, or multiple myeloma, renders the scope of the claim wide that finds little support in the specification. There is no working examples in the specification. It is known that CAR T-cell therapy responds best to blood cancers (hematologic malignancies), especially certain types of leukemia, lymphoma, and multiple myeloma. Post-filing date Cohen, Expert Review of Anticancer Therapy, 2022, 22(9), 903-914, teaches that Axicabtagene ciloleucel is an autologous anti-CD19 chimeric antigen receptor (CAR) T-cell therapy that was recently approved for relapsed or refractory follicular lymphoma following progression on two or more lines of therapy and concludes that pending approval, bispecific T-cell redirectors may allow CAR-T therapy to be delayed until later relapse. Additionally, they may provide greater eligibility than CAR T-cell therapies for patients with otherwise prohibitive comorbidities or rapidly progressive disease, owing to their lower toxicity and off-the-shelf technology. These two treatment modalities will likely become complementary in managing patients with relapsed or refractory FL. Page 912, column A. Likewise, Wang (Combining chemotherapy with CAR-T cell therapy in treating solid tumors. Front Immunol. 2023 Mar 6;14:1140541) teaches that chemotherapy is well known for its cytotoxic effects, which may also have a deleterious effect on CAR-T cell viability and function, inducing apoptosis of immune cells, and often leading to lymphopenia. Further Wang teaches that a limited number of clinical trials have been performed, the combination treatment of chemotherapy and CAR- T cell therapy has significant capacity to improve the current clinical outcomes and is a promising option. Further with respect to ‘administered an alkylating agent at least about six (6) months prior to the time the PBMCs’ Rytlewski, BloodVolume 136, Supplement 1, 5 November 2020, Pages 7-8, concludes that ‘Associations between patient characteristics and alkylator washout suggest that patients who more recently received alkylating agents to manage their myeloma had a more aggressive disease course, having progressed more quickly through prior regimens, and had lower weight and elevated systemic inflammation. Although these factors suggest a suboptimal patient profile, the depletion of T cells by alkylator therapy may be especially disadvantageous for autologous CAR T cell therapies’ . That treatment with alkylating agent any time prior to 6 months does not make much sense. “A conclusion of Iack of enablement means that, based on the evidence regarding each of the above factors, the specification, at the time the application was filed, would not have taught one skilled in the art how to make and/or use the full scope of the claimed invention without undue experimentation. ln re Wright, 999 F.2d 1557,1562, 27 USPQ 2d 1510, 1513 (Fed. Cir. 1993).'' That conclusion is clearly justified here. See MPEP 2164.01(a). Thus, undue experimentation would be required to make and use Applicants' invention. Where the assertion of utility is unusual, difficult to treat or speculative, the examiner has authority to require evidence that tests relied on are reasonably predictive of in vivo efficacy by those skilled in the art. See for example, In re Ruskin 148 USPQ 221; Ex parte Jovanovics 211 USPQ 907. Note MPEP. 2164.05(a). MPEP 2164.05(a): When the best efforts have failed to achieve a goal, it is reasonable for the PTO to require evidence that such a goal has been accomplished, In re Ferens, 163 USPQ 609. Patent protection is granted in return for an enabling disclosure of an invention, not for vague intimations of general ideas that may or may not be workable. Tossing out the mere germ of an idea does not constitute enabling disclosure. The failure of skilled scientists to achieve a goal is substantial evidence that achieving such a goal is beyond the skill of practitioners in that art, Genentech vs. Novo Nordisk, 42 USPQ2nd 1001, 1006. Genentech Inc. v. Novo Nordisk A/S (CA FC) 42 USPQ2d 1001, states “a patent is not a hunting license. It is not a reward for search, but compensation for its successful conclusion” and “[p]atent protection is granted in return for an enabling disclosure of an invention, not for vague intimations of general ideas that may or may not be workable”. THIS ACTION IS MADE FINAL. 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 extension fee 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 NIZAL S CHANDRAKUMAR whose telephone number is (571)272-6202. The examiner can normally be reached M-F 8-5 EST. 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, Andrew Kosar can be reached on (571) 272-0913. 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. Wolf, OncoTargets and Therapy (2018), 11, 1-16 Head and neck squamous cell carcinoma (HNSCC) is an immunosuppressive malignancy characterized by tumor-driven immune-system abnormalities that contribute to disease progression. For patients with surgically resectable HNSCC, treatment is often curative surgery followed by irradiation or chemoradiation in high-risk settings to reduce the risk of recurrence. Poor survival and considerable morbidity of current treatments suggest the need for new therapeutic modalities that can improve outcomes. Defects in antitumor immunity of HNSCC patients include suppressed dendritic cell (DC) maturation, deficient antigen-presenting cell function, compromised natural killer (NK)-cell cytotoxicity, increased apoptosis of activated T lymphocytes, and impaired immune-cell migration to tumor sites. Strategies for relieving immunosuppression and restoring antitumor immune functions could benefit HNSCC patients. IRX-2 is a primary cell-derived biol. consisting of physiol. levels of T-helper type 1 cytokines produced by stimulating peripheral blood mononuclear cells of normal donors with phytohemagglutinin. The primary active components in IRX-2 are IL2, IL1β, IFNγ, and TNFα. In vitro, IRX-2 acts on multiple immune-system cell types, including DCs, T cells, and NK cells, to overcome tumor-mediated immunosuppression. In clin. settings, IRX-2 is administered as part of a 21-day neoadjuvant regimen, which includes addnl. pharmacol. agents (low-dose cyclophosphamide, indomethacin, and zinc) to promote anticancer immunoresponses. In a Phase IIA trial in 27 patients with surgically resectable, previously untreated HNSCC, neoadjuvant IRX-2 increased infiltration of T cells, B cells, and DCs into tumors and was associated with radiol. reductions in tumor size. Event-free survival was 64% at 2 years, and overall 5-yr survival was 65%. Follow-up and data anal. are under way in the multicenter, randomized, Phase IIB INSPIRE trial evaluating the IRX-2 regimen as a stand-alone therapy for activating the immune system to recognize and attack tumors. Cancer Cell Int . 2024 Dec 31;24:438. doi: 10.1186/s12935-024-03628-3 Novel research model for in vitro immunotherapy: co-culturing tumor organoids with peripheral blood mononuclear cells Nadeem, EXPERT OPINION ON DRUG SAFETY2020, VOL. 19, NO. 3, 269–279 Cintio, Frontiers in neuroscience (2020), 14, 603647 Cohen, Expert Review of Anticancer Therapy (2022), 22(9), 903-914 Claims 13-21, 23, 87, 92, 94, 127, 128-130, 132-134 are examined. Immunetherapy Examiner suggested amendments to place the examined claims in condition for allowance. 112-1: REPLACE 'at least about' with a range (the 6 months limit, a critical limitation as argued in the recent Remarks, does not make much sense) 112-1:There is no enabling disclosure working example for the laundry list of cancers that can be treated. Limiting to certain specific disease state, with supporting data would help with reasons of allowance) Double Patenting: Need terminal disclaimer. Applicant understood and agreed to get back soon. Any inquiry concerning this communication or earlier communications from the examiner should be directed to NIZAL S CHANDRAKUMAR whose telephone number is (571)272-6202. The examiner can normally be reached M-F 8-5 EST. 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, Andrew Kosar can be reached at (571) 272-0913. 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. /NIZAL S CHANDRAKUMAR/Primary Examiner, Art Unit 1625
Read full office action

Prosecution Timeline

May 03, 2023
Application Filed
May 06, 2026
Non-Final Rejection mailed — §112, §DOUBLEPATENT
Aug 06, 2026
Response Filed
Aug 31, 2026
Examiner Interview (Telephonic)
Aug 31, 2026
Examiner Interview Summary
Sep 15, 2026
Final Rejection mailed — §112, §DOUBLEPATENT (current)

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Prosecution Projections

3-4
Expected OA Rounds
73%
Grant Probability
91%
With Interview (+18.3%)
2y 3m (~0m remaining)
Median Time to Grant
Moderate
PTA Risk
Based on 1785 resolved cases by this examiner. Grant probability derived from career allowance rate.

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