Prosecution Insights
Last updated: April 19, 2026
Application No. 18/475,042

ENHANCEMENT OF T CELL HOMING TO TUMORS THROUGH AUGMENTATION OF CHEMOKINE RESPONSIVENESS AND ACTIVATION DEPENDENT CHEMOKINE SECRETION

Non-Final OA §103§112
Filed
Sep 26, 2023
Examiner
GUSTILO, ESTELLA M
Art Unit
1646
Tech Center
1600 — Biotechnology & Organic Chemistry
Assignee
Regen Biopharma Inc.
OA Round
1 (Non-Final)
53%
Grant Probability
Moderate
1-2
OA Rounds
3y 4m
To Grant
87%
With Interview

Examiner Intelligence

Grants 53% of resolved cases
53%
Career Allow Rate
28 granted / 53 resolved
-7.2% vs TC avg
Strong +34% interview lift
Without
With
+34.4%
Interview Lift
resolved cases with interview
Typical timeline
3y 4m
Avg Prosecution
41 currently pending
Career history
94
Total Applications
across all art units

Statute-Specific Performance

§101
2.1%
-37.9% vs TC avg
§103
32.2%
-7.8% vs TC avg
§102
13.4%
-26.6% vs TC avg
§112
26.2%
-13.8% vs TC avg
Black line = Tech Center average estimate • Based on career data from 53 resolved cases

Office Action

§103 §112
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. Status of the Claims Claims 1 – 20 are currently pending and are the subject of this Office Action. Information Disclosure Statement No information disclosure statement has been filed in this case. 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office . Therefore, unless the references have been cited by the examiner on form PTO-892, they have not been considered. Claim Objections Claim s 8 is objected to because of the following informalities: c laim 8 lists “interleukin-12” twice . Appropriate correction is required. 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 appl icant regards as his invention. Claim s 3, 9, and 10 – 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 3 recites the limitation "said C D4 cells " in the first line. There is insufficient antecedent basis for this limitation in the claim. Claim 9 recites the limitation "said cancer antigen" in the first line. There is insufficient antecedent basis for this limitation in the claim. Claims 10 – 11 recite the limitation "said T cells" in the first line. There is insufficient antecedent basis for this limitation in the claim. Claim 12 recites the limitation " said CAR said T cell " in the first line . There is insufficient antecedent basis for this limitation in the claim. Claim Rejections - 35 USC § 103 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 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action: A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made. The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows: 1. Determining the scope and contents of the prior art. 2. Ascertaining the differences between the prior art and the claims at issue. 3. Resolving the level of ordinary skill in the pertinent art. 4. Considering objective evidence present in the application indicating obviousness or nonobviousness. This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention. Claims 1 – 3 and 7 – 20 are rejected under 35 U.S.C. 103 as being unpatentable over GU ( WO 2019/091478 A1 , published 05/16/2019 ; see PTO-892: Notice of References Cited). The present application is directed to a method of treating cancer comprising the steps of: a) obtaining a T cell population possessing a T cell receptor (TCR) capable of recognizing one or more tumor antigens; b) transfecting said T cell population with a construct in a manner such that activation of T cell receptor or signaling components associated with said T cell receptor results in stimulation of chemokine production from said T cell; and c) administering said T cell to a patient suffering from cancer. GU is directed to modified immune cells and a method of treating neoplastic or cancer conditions comprising administering to a subject the immune cells (see abstract). GU teaches that the modified immune cell specifically binds to a tumor antigen and mediates an immune cell activation signal (see claim 1); that the modified immune cell is a T cell that binds to a neoantigen via a TCR (see claims 3 – 4) ; that the neoantigen is EGFR (see claim 7) ; that the T cell elicits an immune cell activation signal upon binding to its ligand (see claim 9) ; that said immune cell activation signal is mediated by an activation factor (see claim 13), and that said activation factor is a soluble cytokine, a soluble chemokine, or a growth factor (see claim 14). GU teaches that the activation signal is mediated by cytokine/chemokine release by the modified T cells. See ¶¶ 0013, 0014, 0055 and 00116 . GU teaches that the modified T cell overexpresses a chemokine (see ¶ 00145) and teaches a method of treating a cancer of a subject, comprising: (a) administering a modified T cell (see ¶ ¶ 0042 and 0154 ). GU teaches that method of delivery can involve contacting a target polynucleotide or introducing into a cell (or a population of cells such as immune cells) one or more nucleic acids comprising nucleotide sequences encoding the compositions and that the delivery method can be transfection (see ¶ 00187 – 0188). Thus, from the teachings of GU , it would having been obvious to arrive to the method s of present claim s 1 , 9, and 12 and treat cancer with the modified and activatable T cells of Gu . Regarding claim 2, GU teaches that the cell can be any immune cell, including any T-cell such as tumor infiltrating cells (TILs ), such as CD3+ T-cells, CD4+ T-cells, CD8+ T-cells, or any other type of T-cell (see ¶ ¶ 00166, and 00168 ). Regarding claim 3, GU teaches that CD4+ T cells can be subdivided into four sub-sets - Thl , Th2, Thl 7, and Treg (see ¶ 00166, p. 48), and thus it would have been obvious that the T cells used in the method may be a sub-set from the CD4+ T cells listed in present claim 3 and in GU . Regarding claim 7 , GU teaches a co-stimulatory molecule that mediates an immune cell activation signal (see claim 1). Regarding claim 8, GU teaches that said co-stimulatory molecule is CD40 (see claim 12). Regarding claims 10 and 11, GU teaches that the chemokine is CXCL10 and CXCL11 (see ¶ 00151). Regarding claims 12 , GU teaches the modified T cell overexpresses a c ytokine (see ¶ 00145) . Regarding claim 13 – 17, GU teaches that the cytokine is IFN or any functional fragment or variant thereof including IFN s alpha, beta and gamma (see ¶ ¶ 0013 , 0149 and 0151 ). Regarding claim 18, GU teaches that the c ytokine release by the modified immune cell can comprise the release of IL-17 (see ¶ 00119 , ¶ 00149 , and 0150 ). Regarding claim s 19 and 20 , GU teaches that e xamples of cytokines that can be overexpressed by immune cells include LIGHT and TRAIL (see ¶ 00149 and 0151 ). Claims 4 – 6 are rejected under 35 U.S.C. 103 as being unpatentable over GU as applied to claims 1 – 3 and 7 – 20 above and further in view of AZAROV ( Azarov I, et al. (2019) Role of T Cell-To-Dendritic Cell Chemoattraction in T Cell Priming Initiation in the Lymph Node: An Agent-Based Modeling Study. Front. Immunol. 10:1289; see PT0-892). The teachings of GU is discussed above and incorporated here. AZAROV is directed to the role of T cell-to-dendritic cell chemoattraction in T cell priming initiation (see abstract). AZAROV teaches that physiologically, local chemoattraction, or chemotaxis, may be mediated by a concentration gradient of specific chemokine molecules around DCs (see p. 3, T Cell Motion Toward a Neighboring DC via a Chemoattraction Process:) . Thus, because the T cells taught by GU overexpress chemokines, it would have been obvious that the T cell population is capable of inducing chemoattraction of dendritic cells as recited in present claim 4. Regarding claims 5 – 6, AZAROV teaches that T cells may encounter dendritic cells (DCs) presenting cognate antigens as MHC-bound peptides ( pMHC ) on their surface (Introduction) , rendering the limitations of present claims 5 – 6 obvious. Conclusion No claim is allowed. Any inquiry concerning this communication or earlier communications from the examiner should be directed to FILLIN "Examiner name" \* MERGEFORMAT Estella Gu stilo whose telephone number is FILLIN "Phone number" \* MERGEFORMAT (703)756-1706 . The examiner can normally be reached FILLIN "Work Schedule?" \* MERGEFORMAT Monday - Friday 9:30 AM - 5:30 PM . 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, FILLIN "SPE Name?" \* MERGEFORMAT Gregory Emch can be reached at FILLIN "SPE Phone?" \* MERGEFORMAT 571-272-8149 . 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. /ESTELLA M . G U STILO/ Examiner, Art Unit 1646 /PETER J REDDIG/ Primary Examiner, Art Unit 1646
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Prosecution Timeline

Sep 26, 2023
Application Filed
Mar 19, 2026
Non-Final Rejection — §103, §112 (current)

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Study what changed to get past this examiner. Based on 5 most recent grants.

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Prosecution Projections

1-2
Expected OA Rounds
53%
Grant Probability
87%
With Interview (+34.4%)
3y 4m
Median Time to Grant
Low
PTA Risk
Based on 53 resolved cases by this examiner. Grant probability derived from career allow rate.

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