Prosecution Insights
Last updated: April 19, 2026
Application No. 17/605,639

GENE KNOCK-OUTS TO IMPROVE T CELL FUNCTION

Non-Final OA §102§112
Filed
Oct 22, 2021
Examiner
ABBOTT, KODYE LEE
Art Unit
1634
Tech Center
1600 — Biotechnology & Organic Chemistry
Assignee
St. Jude Children's Research Hospital
OA Round
3 (Non-Final)
47%
Grant Probability
Moderate
3-4
OA Rounds
2y 2m
To Grant
99%
With Interview

Examiner Intelligence

Grants 47% of resolved cases
47%
Career Allow Rate
9 granted / 19 resolved
-12.6% vs TC avg
Strong +67% interview lift
Without
With
+66.7%
Interview Lift
resolved cases with interview
Typical timeline
2y 2m
Avg Prosecution
30 currently pending
Career history
49
Total Applications
across all art units

Statute-Specific Performance

§101
6.3%
-33.7% vs TC avg
§103
34.7%
-5.3% vs TC avg
§102
23.6%
-16.4% vs TC avg
§112
31.4%
-8.6% vs TC avg
Black line = Tech Center average estimate • Based on career data from 19 resolved cases

Office Action

§102 §112
DETAILED ACTION 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 . Continued Examination Under 37 CFR 1.114 A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 10/03/2025 has been entered. Claims 1, 44-45, 48-51, 53-55, 58, 60-62, 64, 78, 84-85, 95, 97, and 141-143 are pending. Claims 1 and 141 are independent claims. Applicant amended claims 44, 49, 141, and 142 by amendment filed on 09/22/2025. Claims 1, 58, 60-62, 64, 85, 95, and 97 are withdrawn from consideration pursuant to 37 CPR 1.142(b) as being drawn to a nonelected subject matter, there being no allowable generic or linking claims. Claims 2-43 were previously cancelled by amendment filed 04/11/2025. Therefore, claims 44, 45, 48-51, 53-55, 78, 84, and 141-143 are currently under examination to which the following grounds of rejection are applicable. Priority The instant application is a national stage entry under 35 USC 371 of PCT/US2020/029533 Acknowledgment is made of applicant’s claim for foreign priority under 35 U.S.C. 119 (a)-(d). The certified copy has been filed on 10/22/2021. Review of the priority documents provides no literal or figurative support for the claimed invention of “a T cell specific for a tumor antigen”. At the most, the following support is found for a T-cell specific for a tumor antigen: 1) The term “anti-tumor function” is defined in paragraph [0136] of the published application to refer to the ability of a T cell to inhibit tumor growth and/or to kill the tumor cells (cancer cells).”, 2) the description of embodiments to include T cells engineered to express a CAR that can target a tumor antigen or infectious antigen in paragraphs [0008], [0024], [0047], [0137], 3) additional descriptions of a T cell that may have the ability to target a tumor antigen or infectious agents [136]. Paragraphs [136] to [148] describe only non-limiting examples of potential T cells, CARs and antigens. The paragraphs nor the rest of the specification provides clarity to ascertain the metes and bounds of the T cell, antigen, or CAR. Therefore, the priority date for the claimed limitation “a T cell specific for a tumor antigen” is not found in the disclosure of the instant U.S. Application filed on 10/22/2021. Information Disclosure Statement The information disclosure statement (IDS) submitted on 04/11/2025, was filed before the mailing date of the Non-final office action. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner. Maintained and modified rejections in response to Applicants’ arguments or amendments Claim Interpretation Claims 44 and 141 has been amended to recite “a T cell specific for a tumor antigen”. This term is not supported by the specifications (see relevant 112a rejection below). Please note that claim 44 and 141 in the previous amendments filed 04/11/2025 recited the phrase “an anti-tumor t cell”. This term was determined to not be supported by the specification and was also rejected under 112a for new matter. Note that paragraph [0136] of the published application states: “The term “anti-tumor function” as used herein refers to the ability of a T cell to inhibit tumor growth and/or to kill the tumor cells (cancer cells).” Paragraphs [0008], [0024], [0047], [0137] of the published application describes only T cells engineered to express a CAR that can target a tumor antigen or infectious antigen, paragraph [136] describes a T cell that may have the ability to target a tumor antigen or infectious agents. Paragraphs [136] to [148] describe only non-limiting examples of potential T cells, CARs and antigens. The paragraphs nor the rest of the specification provides clarity to ascertain the metes and bounds of the T cell, antigen, or CAR. The phrase “a T cell specific for a tumor antigen” is not supported by the instant application. For the purpose of compact prosecution, the phrase will be interpreted as any Tcell with the capacity to recognize/bind any tumor antigen. Claim Rejections - 35 USC § 102 In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status. 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. (a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention. Note: The rejection is modified for consideration of the amendments filed 9/29/2025. To the extent the that the phrase “a T cell specific for a tumor antigen”, is interpreted as a as any T cell with the capacity to recognize/bind any tumor antigen, the following rejection stands. Claim(s) 44-45,48-51,53-55, 78, 84 and 141-143 remain rejected under 35 U.S.C. 102(a)(1) as being anticipated by Xin et al. (Xin, G et al., Cell Rep., 2015) as evidenced by Gale et al. (Gale et al., Hematology and Oncology Merck Manual, 2024) and Blohm et al. (Blohm U., Eur J Immunol. 2006). Regarding Claims 44, Xin et al. teaches a method resulting in the enhanced expansion of T-cells. Specifically, Xin et al teaches that BATF-overexpressing CD8 T cells (BATF-Thy1.1+) contained a significantly higher proportion of proliferating cells (as measured by Ki67+) and had increased survival (as measured by Annexin-V−7-AAD− [7-amino-actinomycin D]) compared with empty MIT-transduced cells (control-Thy1.1+) (page 3, last paragraph; Figures 3B and 3C). Further, the P14 T cells taught by Xin et al. contain the P14 TCR which is a TCR commonly used in the field that has been engineered to recognize an epitope (GP33) of the lymphocytic choriomeningitis virus (LCMV). Cancer cells are commonly engineered to express this viral epitope, after which it is considered a cancel cell/tumor antigen as evidenced by Gale et al. and Blohm et al. below). Gale et al. describes antigens as follows, “Many tumor cells produce cancer-associated or cancer-specific molecules, usually peptides, which may be released in the blood or displayed on the cell surface. Any molecule capable of being recognized by the immune system and triggering an immune response is considered antigenic.” Blohm et al. teaches the use of GP33 as a model cancer antigen. “Here, we visualized the anti-tumor response of CD8 T cells from P14 TCR-transgenic mice specific for the model antigen GP33 by immunohistology. P14 T cells, adoptively transferred into tumor-bearing hosts, induced regression of established 3LL-A9(GP33) and MCA102(GP33) tumors that express GP33 as a tumor-associated model antigen.” (Abstract). Regarding Claims 45, 48-49, Xin et al. teaches that the T cells used in the method described above are CD8+ T cells, with transduced cells identified by Thy1.1 expression, more specifically CD8 T cells from P14 T cell receptor (an alpha-beta TCR) donor mice cells. (Pg. 3-4, Section: BATF Overexpression Enhances CD8 T Cell Response). Further, the P14 T cells taught by Xin et al. contain the P14 TCR (for claim 48) which is a TCR commonly used in the field that has been engineered to recognize an epitope of the lymphocytic choriomeningitis virus (LCMV) (for claim 49). PNG media_image1.png 181 990 media_image1.png Greyscale Regarding Claim 50-51 and 53-55, Xin et al. teaches the use of a BATF gene containing vector used to overexpress BATF using the spin transfection method (Pg. 8, Experimental Procedures, Retrovirus-Mediated BATF Overexpression). The vector used by Xin et al. contains a vector with the sequence encoding for BATF, which anticipates the instant application claim 51 for the polynucleotide encoding a BATF protein comprising nucleotide sequence of SEQ ID NO:27 (the full sequence of mRNA encoding for BATF, see alignment below). Further, the BATF vector taught by Xin et al. is incorporated into a retrovirus (for claims 54-55) and is a recombinant vector (for claim 53) (Pg. 8, Experimental Procedures, Retrovirus-Mediated BATF Overexpression). Regarding Claim 78 and 84, Xin et al. teaches generation and introduction of the generated P14 T cells into C57BL/6 mice. Specifically, “To explore whether BATF was sufficient to augment effector function, the retroviral vector (RV) MSCV-IRES-Thy1.1 (MIT) was used to overexpress BATF in CD8 T cells, with transduced cells identified by Thy1.1 expression. To facilitate the detection, we used CD8 T cells from P14 TCR (LCMV GP33-specific) transgenic mice as donor cells. First, CD45.1+ P14 cells were transduced with either an empty MIT or a BATF overexpressing (BATF-MIT) vector in vitro, and then a small number (∼5,000/mouse) of the P14 cells were immediately transferred into congenic B6 mice…” (Pg. 3-4, Section: BATF Overexpression Enhances CD8 T Cell Response). The production of these BATF over expressing T cells by the methods of Xin et al. (described above) result in the production of the T cells introduced into the mice which anticipates the T cells of claim 78. Further, the description of the P14 cells being transferred into congenic mice would inherently require an acceptable carrier/excipient, otherwise the composition comprising the T cells could not be delivered to the mouse. Therefore, this anticipates the use of the T cells with a pharmaceutically acceptable carrier/excipient recited in claim 84. Regarding Claims 141-143, as discussed above Xin teaches a method of enhancing expansion of a T cell +) (Figures 3B and 3C). Xin et al. teaches that the T cells used in the method described above are CD8+ T cells, with transduced cells identified by Thy1.1 expression, more specifically CD8 T cells from P14 T cell receptor (an alpha-beta TCR) donor mice cells. (Pg. 3-4, Section: BATF Overexpression Enhances CD8 T Cell Response). Further, the P14 T cells taught by Xin et al. contain the P14 TCR, which is a TCR commonly used in the field that has been engineered to recognize an epitope of the lymphocytic choriomeningitis virus (LCMV), a known tumor antigen. Response to Applicants’ Arguments as they apply to the rejection of claim(s) 44-45, 48-51, 53-55, 78, 84, and 141-143 under 35 U.S.C. 102 At pages 7-8 of the remarks filed on 09/22/2025, Applicants essentially argue that the rejection of claims be withdrawn as “the claimed T cell specific for a tumor antigen is patentably distinct from the anti-viral T cell disclosed in Xin. At the time of filing the present application, one of ordinary skill in the art would have known that such T cells are distinct from anti-viral T cells.”. Please note: Applicant has previously elected “enhancing expansion” as the species to be examined. Therefore, persistence and functions are drawn to unelected subject matter. Additionally, Applicants’ arguments have been considered, but have not been found persuasive. On page 7 of the remarks filed on 09/22/2025, Applicant argues “At the time of filing the present application, one of ordinary skill in the art would have known that anti-tumor T cells are distinct from anti-viral T cells.” On pg. 7-8, Applicant further argues that “one of ordinary skill at the time of the invention would have recognized such differences and would not have reasonably expected that overexpression of a gene product in an anti-viral T cell would have the same effect as overexpression of the same gene product in a T cell specific for a tumor antigen.” Applicant refers to the teachings of Phillip and Schietinger et al. (of record) summarizing them as “T cells that are specific for viral antigens are very different from T cells specific for tumor antigens.” At pg. 7-9 Applicant points to teachings of Phillip et al. (of record), which broadly teaches differences in T cell differentiation in response to infection versus in response to the occurrence of tumor. While the teachings of Phillip et al. demonstrate a scenario of CD8+ T cell differentiation to dysfunctional states during tumorigenesis, these teachings do not serve to differentiate the claimed T cell with the capacity for tumor antigen recognition from those disclosed by Xin. Phillip also teaches viral antigen release from tumor cells in the first paragraph of the introduction, “CD8+ T cells have the ability to selectively detect and eradicate cancer cells. Tumours express antigens, which include tumour-specific (mutant and viral) neoantigens and self-antigens (also known as tumour-associated or shared antigens) and CD8+ T cells reactive against such antigens are found in patients with cancer.”. These teachings remove the possibility of clear separation of a genus of viral antigen from that of a tumor antigen without providing a specific species of tumor antigen that has no associated viral origin. Further, T cells can possess a cross reactivity which provides the possibility for a T cell to recognize both antigens originating from a virus and an antigen not associated with a virus that originates from a tumor. For example, Chiou et al. teaches cross reactivity to multiple antigenic epitopes and shared specificities of T cells, including specific tumor antigens and viral antigens (Abstract; Introduction, 3rd Paragraph). Note: The applicant is on record as stating that the ordinary artisan would have had no reason to expect anti-viral T cells were not distinct from anti-tumor T cells (See page 7, last para. of Applicants ‘remarks filed on 4/11/2025 and 9/29/2025). At Pg. 9-10 of the remarks, applicants provide the teachings of Schietinger et al. (of record), asserting Schietinger et al. discloses that although there are similarities between dysfunctional T cells encountering a tumor-specific neoantigen in non-inflammatory, premalignant lesions and T cells during chronic viral infection. Similar to the teachings of Phillip discussed above, these teachings are in reference to a context specific T cell response and do not serve to differentiate the claimed T cell from the t cell disclosed by Xin. Xin et al. discloses a CD8 T cell that when transfected with a recombinant vector comprising a nucleic acid to overexpresses a BATF gene product ultimately results in CD8 T cell persistence and anti-viral effector function (Abstract). Moreover, Xin et al. teaches that BATF-overexpressing CD8 T cells (BATF-Thy1.1+) contained a significantly higher proportion of proliferating cells (as measured by Ki67+) and had increased survival (as measured by Annexin-V−7-AAD− [7-amino-actinomycin D]) compared with empty MIT-transduced cells (control-Thy1.1+) (page 3, last paragraph; Figures 3B and 3C). Therefore, if transfecting CD8 T cells with a recombinant vector to induce overexpression of a BATF gene product results in results in increased proliferation, persistence and anti-viral effector function of the CD8 T cells, then it stands to reason that transfecting CD8 T cells with a recombinant vector to overexpress a BATF gene product would be reasonably expected to promote CD8 T cell proliferation, persistence, and anti-tumor antigen effector function for the same reason as anti-viral antigens as both tumor antigens and viral antigens induce chronic stimulation of CD8 T Cells. Note: The applicant is on record as stating that the ordinary artisan would have had no reason to expect anti-viral T cells were not distinct from anti-tumor T cells (See page 7, last para. of Applicants ‘remarks filed on 4/11/2025 and 9/29/2025). At Pg. 10, final paragraph of remarks filed 09/22/2025, applicant argues against the examiners discussion of Rosato et al. and the ability for a T cell to affect a tumor is context dependent. Applicant points to teaching of Rosato et al., specifically “In Rosato, virus-specific memory T cells were shown to extend their surveillance to mouse and human tumors. See Rosato, e.g., p. 2. It was also further shown that "these functional T cells can be specifically reactivated via local delivery of adjuvant-free viral peptide." See Rosato, p. 2. Specifically, if viral peptides were injected into tumors, these tumors had delays in growth kinetics. See Rosato, p. 2. In other words, artificially inducing an anti-viral memory T cell's natural immune response within a tumor caused the immune system to react to the viral peptides present within the tumor. This highly artificial scenario does not equate to an anti-tumor effect - instead, the antiviral T cell's anti-viral function has been co-opted into an anti-tumor response.” Applicants’ arguments have been considered, but have not been found persuasive. Examiner maintains the ability for a T cell to affect a tumor is context dependent. As in the context taught by Rosato et al., the antiviral T cell was clearly shown to produce an anti-tumor response. These teachings are provided above from the applicants’ remarks and also in the previous office action filed 7/23/2025. The instant claims as written do not preclude the scenarios taught by Rosato et al. The instant claims as written do not require a T cell be ONLY responsive to a tumor antigen under set parameters. The instant claims as written do not provide a specific tumor antigen of non-viral origin. The claims do not exclude antiviral responsive T cells with the capacity to bind tumor antigens. Finally, Applicant argues lymphocytic choriomeningitis virus (LCMV) is not a known tumor antigen. Applicant points to the teachings of Rosato, "GP33 peptide from a different virus (LCMV) that had not been experienced by these mice had no effect, indicating that tumor control was dependent on antigen-specific reactivation of pre-existing antiviral immunity." See Rosato, p. 2. Xin also clearly discloses that LCMV is a virus, consistently stating throughout the article that mice were chronically or acutely infected with LCMV, and that virus-specific CD8 T cell responses were induced by this infection. Applicant concludes that “At the time of the invention, as demonstrated by Xin and Rosato, one of ordinary skill in the art would have known that LCMV is a virus and that it induces virus-specific CD8 T cell responses.” Applicants’ arguments have been considered, but have not been found persuasive. As stated below in the 112b rejection of claim 44, the instant disclosure does not provide a description that would define the metes and bounds of what is considered a tumor antigen. The specification provides a list of non-limiting examples at paragraphs [00138] and [00139]. However, this list nor any other description in the instant specification does not preclude an epitope on LCMV from being a tumor antigen. Gale et al. (Gale et al., Hematology and Oncology Merck Manual, 2024, 2024) describes antigens as follows, “Many tumor cells produce cancer-associated or cancer-specific molecules, usually peptides, which may be released in the blood or displayed on the cell surface. Any molecule capable of being recognized by the immune system and triggering an immune response is considered antigenic.” Blohm et al. (Blohm U., Eur J Immunol. 2006) teaches the use of GP33 as a model cancer antigen. “Here, we visualized the anti-tumor response of CD8 T cells from P14 TCR-transgenic mice specific for the model antigen GP33 by immunohistology. P14 T cells, adoptively transferred into tumor-bearing hosts, induced regression of established 3LL-A9(GP33) and MCA102(GP33) tumors that express GP33 as a tumor-associated model antigen.” (Abstract). Xin et al. teaches that the T cells used in their invention have a TCR that can recognize lymphocytic choriomeningitis virus (LCMV), a known tumor antigen. This is demonstrated by the method and cells of Xin as described above, CD8+ T cells, with transduced cells identified by Thy1.1 expression, more specifically CD8 T cells from P14 T cell receptor (an alpha-beta TCR) donor mice cells. (Pg. 3-4, Section: BATF Overexpression Enhances CD8 T Cell Response). The P14 T cells taught by Xin et al. contain the P14 TCR, which is a TCR commonly used in the field that has been engineered to recognize an epitope of the lymphocytic choriomeningitis virus (LCMV) GP33, which has been use to study immune response in systems containing cancer cells engineered to express GP33. As the instant specification does not provide specific support or requirements for what constitutes a cancer antigen in relation to their invention, a system comprising a cancer cell engineered to express a viral epitope as an antigen is considered as relevant art. (See 112b rejection below). As discussed above, the teachings of Xin anticipate claimed method of the instant application. Claim Rejections - 35 USC § 112(b) Claims 44, 45, 48-51, 53-55, 78, 84, and 141-143 are remain rejected under 35 USC § 112(b) 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. Note: The rejection is modified in consideration of the amendments filed 9/29/2025. Claim 44 recites “A method of enhancing expansion and/or persistence and/or a function of a T cell specific for a tumor antigen…”. The phrase “T cell specific for a tumor antigen” lacks objective boundaries and it is unclear what the applicants’ intended meaning actually is. Therefore, the claim is indefinite. While the specification describes antitumor function of T cells, it does not ascribe a specific meaning to a “T cell specific for a tumor antigen.” Does this applicant intend this to exclude T cells with the capacity for cross reactivity between viral infection and cancer cells or is there a specific T cell – antigen – tumor requirement? Does the applicant intend that the “T cell specific for a tumor antigen” recognizes a naturally occurring tumor antigen? ? Does the applicant intend that any antigens of viral origin be excluded regardless of context? Does the applicant intend to differentiate between tumor associates antigens and tumor specific antigens? Applicant must plainly define the cell and tumor antigen they intend to claim. As such the meets and bounds of the claims are indefinite. For the purpose of examination, any T cell with the capacity to recognize any tumor/cancer related antigen in any context will be considered. Claim 44 is indefinite because of its recitation of a function in lines 2 and 3 as it is unclear as to “the function ” or functions that are intended as being encompassed by the noted phrase. For example, T cells are known in the prior art to have numerous activities, both specific and general. All T cells mediate cell-based immune responses to fight infections and potentially cancer. Further, the metes and bounds of “enhanced function” with respect to the BATF protein are not established in the claim. It is suggested that applicant clarify the intended meaning of the noted phrase. Claims 45, 48-51, 53-55, 78, 84 depend from claim 44 and inherit these deficiencies. Claim 141 recites “T cell specific for a tumor antigen”. The term “T cell specific for a tumor antigen” lacks objective boundaries and it is unclear what the applicants’ intended meaning actually is. Therefore, the claim is indefinite. While the specification describes antitumor function of T cells, it does not ascribe a specific meaning to an anti-tumor T cell. While the specification describes antitumor function of T cells, it does not ascribe a specific meaning to a “T cell specific for a tumor antigen.” Does this applicant intend this to exclude T cells with the capacity for cross reactivity between viral infection and cancer cells or is there a specific T cell – antigen – tumor requirement? Does the applicant intend that the “T cell specific for a tumor antigen” recognizes a naturally occurring tumor antigen? Does the applicant intend that any antigens of viral origin be excluded regardless of context? Does the applicant intend to differentiate between tumor associates antigens and tumor specific antigens? Applicant must plainly describe the cell and tumor antigen they intend to claim. For the purpose of examination, any T cell with the capacity to recognize any tumor/cancer related antigen will be considered. Claims 142-143 depend from claim 141 and inherit the deficiencies. Claim Rejections - 35 USC § 112(a)- New matter rejection 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. Note: The rejection is modified in consideration of the amendments filed 9/29/2025. Claims 44-45, 48-51, 53-55, 78, 84 and 141-143 rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. MPEP § 2163.II.A.3.(b) states, “when filing an amendment an applicant should show support in the original disclosure for new or amended claims” and “[i]f the originally filed disclosure does not provide support for each claim limitation, or if an element which applicant describes as essential or critical is not claimed, a new or amended claim must be rejected under 35 U.S.C. 112, para. 1, as lacking adequate written description”. According to MPEP § 2163.I.B, “While there is no in haec verba requirement, newly added claim limitations must be supported in the specification through express, implicit, or inherent disclosure” and “The fundamental factual inquiry is whether the specification conveys with reasonable clarity to those skilled in the art that, as of the filing date sought, applicant was in possession of the invention as now claimed. See, e.g., Vas-Cath, Inc., 935 F.2d at 1563-64, 19 USPQ2d at 1117”. Claims 44 and 141 have been amended to recite, “T cell specific for a tumor antigen”. On page 6 of the remarks filed on 09/29/2025, Applicant asserts support for these amendments can be found for example in paragraphs [0140] - [0142]. It appears the paragraphs correspond to paragraphs [136] to [138] of the specification filed 10/22/2021, referenced by the examiner throughout all of the prosecution to date.However, paragraphs [136] to [138] of the specification filed 10/22/2021 describe only non-limiting examples of potential T cells, CARs and antigens. Neither these paragraphs, nor the rest of the specification provides clarity to ascertain the metes and bounds of the claimed Tcell, antigen, or CAR. Therefore, there is not sufficient written description to support the new matter “T cell specific for a tumor antigen”. The applicant has not properly described what they intend to claim as an “T cell specific for a tumor antigen”. Thus, the specific embodiments regarding the breadth of T cell specific for a tumor antigen sets forth new functions T cells not previously disclosed as a contemplated embodiment in the present specification, nor one that was readily known and used in the art at the time of filing. Hence, is not clear that the Applicant was in possession of a genus of undefined “T cells specific for a tumor antigen” before the effective filing date of the claimed invention. Claims 44, 45, 48-51, 53-55, 78, 84, and 141-143 will remain rejected until Applicant cancels all new matter. Conclusion Claims 44, 45, 48-51, 53-55, 78, 84, and 141-143 are rejected. No claim is allowed. Any inquiry concerning this communication or earlier communications from the examiner should be directed to KODYE LEE ABBOTT whose telephone number is (703)756-1111. The examiner can normally be reached M-F 8-5. 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, Maria G. Leavitt can be reached on (571) 272-1085. 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. /KODYE LEE ABBOTT/Examiner, Art Unit 1634 /MARIA G LEAVITT/Supervisory Patent Examiner, Art Unit 1634
Read full office action

Prosecution Timeline

Oct 22, 2021
Application Filed
Oct 22, 2021
Response after Non-Final Action
Jan 08, 2025
Non-Final Rejection — §102, §112
Apr 11, 2025
Response Filed
Jul 21, 2025
Final Rejection — §102, §112
Sep 22, 2025
Response after Non-Final Action
Oct 03, 2025
Request for Continued Examination
Oct 07, 2025
Response after Non-Final Action
Oct 16, 2025
Non-Final Rejection — §102, §112 (current)

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Prosecution Projections

3-4
Expected OA Rounds
47%
Grant Probability
99%
With Interview (+66.7%)
2y 2m
Median Time to Grant
High
PTA Risk
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