Prosecution Insights
Last updated: April 19, 2026
Application No. 18/472,445

TARGETING THE IMMUNE SUPPRESSIVE TUMOR MICROENVIRONMENT

Non-Final OA §102§103
Filed
Sep 22, 2023
Examiner
OGUNBIYI, OLUWATOSIN A
Art Unit
1645
Tech Center
1600 — Biotechnology & Organic Chemistry
Assignee
Brown University
OA Round
1 (Non-Final)
63%
Grant Probability
Moderate
1-2
OA Rounds
3y 1m
To Grant
99%
With Interview

Examiner Intelligence

Grants 63% of resolved cases
63%
Career Allow Rate
579 granted / 914 resolved
+3.3% vs TC avg
Strong +43% interview lift
Without
With
+42.9%
Interview Lift
resolved cases with interview
Typical timeline
3y 1m
Avg Prosecution
45 currently pending
Career history
959
Total Applications
across all art units

Statute-Specific Performance

§101
5.5%
-34.5% vs TC avg
§103
26.4%
-13.6% vs TC avg
§102
24.0%
-16.0% vs TC avg
§112
26.4%
-13.6% vs TC avg
Black line = Tech Center average estimate • Based on career data from 914 resolved cases

Office Action

§102 §103
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. Claims 1-16 are pending and are under examination. 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. Claim(s) 1, 6, 11 and 12 is/are rejected under 35 U.S.C. 102 (a)(1) as being anticipated by Hermonat, Paul (“Hermonat”) . US 2011/002961 1/6/2011. Claim 1: Hermonat disclose a dendritic cell (an immune suppressor cell) modified to include IL-12 (an innate immune effector). Claim 6: Hermon at et al disclose a method of treating cancer, comprising administering an effective amount of a dendritic cell (an immune suppressor cell) modified to include IL-12 (an innate immune effector). Claims 11-12: Hermonat disclose the cancer is a carcinoma and lymphoma. Hermonat disclose the cancer is breast cancer, colon cancer, bladder cancer and prostate cancer. See claims. Claim(s) 1, 6 and 11-16 is/are rejected under 35 U.S.C. 102 (a)(1) as being anticipated by Studeny et al. US 2004/0076622 4/22/2004. Claim 1: Studeny et al disclose a mesenchymal stem cell (MSC, immune suppressor cell) modified to include interferon beta (innate immune effector) or IL-12 immune effector etc. See abstract, paragraph 9, claims 1-81 and paragraph 120 Claim 6: Studeny et al disclose a method of treating cancer in a subject comprising administering an effective amount of the modified MSC to the subject. Claim 11-12: Studeny et al disclose the cancer is human cancers including that of prostate, lung, brain, glioma, neuroblastoma, skin, liver, breast , lymphoid system, multiple myelomas, lymphomas, stomach, testicular, ovarian, pancreatic, bone, bone marrow, head and neck, cervical, esophagus, eye, gall bladder, kidney, adrenal glands, heart, colon, rectum and blood . See paragraph 146. Claim 13: Studeny et al disclose the cancer is drug-resistant cancer. See paragraph 145. Claim 14: Studeny et al disclose the method of treatment further comprises an additional cancer therapy to treat the subject. See paragraphs 136-144. Claim 15: Studeny et al disclose the method of treatment further comprises an additional cancer therapy to treat the subject such as an antibody. See paragraphs 129-131 and 136. Claim 16: Studeny et al disclose the modified MSC cells are administered intratumorally. See paragraph 160. Claim(s) 1 and 3- 5 is/are rejected under 35 U.S.C. 102 (a)(1) as being anticipated by Fakiruddin et al . Biology . 2021; 10(11):1103. https://doi.org/10.3390/biology10111103 as evidenced by GENBANK accession no. NM_003810.2 5-23-2010 and as evidenced by NCBI Reference Sequence Accession number NP_003801 9/187/22 . Claim 1, 3: Fakiruddin et al disclose a mesenchymal stem cell (MSC, immune suppressor cell) transduced (modified) to include TRAIL. See title, simple summary, abstract. Claim 4- 5: Fakiruddin et al disclose that the nucleic acid of the TRAIL is human TRAIL gene accession number NM_003810.2 which includes a nucleic acid sequence having 95% sequence identity to SEQ ID NO: 2 (see Appendix A attached) and Fakiruddin et al disclose the nucleic acid sequence is operably linked to a promoter in a lentivirus vector. See section 2.3. As evidenced by NCBI Reference Sequence accession number NP_003801 the amino acid sequence of human TRAIL comprises an amino acid sequence that is 100% identical to SEQ ID NO: 1. Claim(s) 1-2, 6-7 and 11 -15 is/are rejected under 35 U.S.C. 102 (a)(1) as being anticipated by Gregori et al . US 2018/0050092 2/22/2018. Claims 1-2: Gregori et al disclose an immune suppressor cell regulatory T cell (Tr1-like) modified in include IL-10 ( an innate immune effector). See paragraph 2 and 6. Claim 6-7 , 12-13 : Gregori et al disclose a method of treating cancer in a subject comprising administering an effective amount of an immune suppressor cell regulatory T cell (Tr1-like) modified in include IL-10 ( an innate immune effector) , wherein the cancer is breast, colon , bladder, prostate, lung cancer, lymphoma, sarcoma, and drug resistant cancer. See paragraph s 2, 6, 8, 22, 54 and 55 . Claim 14-15, Gregori et al disclose the method of treatment further comprises immune checkpoint therapy or antibodies. See paragraph 44-45. Claim(s) 1 -12 and 14-15 is/are rejected under 35 U.S.C. 102 (a)(1) as being anticipated by Chen et al. WO 2012/054747 4/26/2013 as evidenced by GENBANK accession no. NM_003810.2 5-23-2010 and as evidenced by NCBI Reference Sequence Accession number NP_003801 9/187/22. Claim s 1 -2 : Chen et al disclose a myeloid-derived suppressor cell (MDSC) that comprises a nanoparticle conjugated to and innate immune effector such as toll-like receptor ligand such as TLR2 ligand, TLR9 ligand , TLR4 ligand , CpG , LPS , TNFα, or adenovirus comprising TRAIL (ADITRAIL-EI) conjugated the MDSC . Chen et al disclose alternatively that the nanoparticle /oncolytic virus is phagocytosed/taken-up by the MDSC. See paragraph s 7, 58, 60, 74-75, 87, 88, 91, 93 and claims 1-40. Claim 3: Chen et al disclose that the innate immune effector is TRAIL. S ee paragraph 7, 58, 60, 74 -75 , 87, 88, 91, 93 and claims 1-40. Claims 4-5: As evidenced by gene accession number NM_003810.2 TRAIL includes a nucleic acid sequence having 95% sequence identity to SEQ ID NO: 2 (see Appendix A attached) As evidenced by NCBI Reference Sequence accession number NP_003801 the amino acid sequence of human TRAIL comprises an amino acid sequence that is 100% identical to SEQ ID NO: 1. Chen et al disclose that the adenovirus, Adl TRAIL -EI, is a recombinant adenovirus with the viral replicative gene, EI, as well as the gene for tumor necrosis factor-related apoptosis- inducing ligand (TRAIL ) driven by human telomerase reverse transcriptase promoter (hTERT). See paragraph 4. Claim 6- 10 : Chen et al disclose a method of treating cancer in a subject, comprising administering an effective amount of the modified MDSC cell to a subject. See paragraphs 106-112 Claim 11 -12 : Chen et al disclose the cancer is breast, sarcoma, carcinoma, colon , lung, bladder, and prostate cancer. See paragraph 12. Claim 14: Chen et al disclose addition type of cancer therapy used to train the subject. See paragraph 89, 110-112. Claim 15: Chen et al disclose the treating of cancer further comprises administration of antibodies. See paragraph 62 and 91 . Chen et al disclose administering the MDSCs by injection and that they can be administered in any way known in the art. Claim Rejections - 35 USC § 103 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. Claim (s) 6 and 8- 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Fakiruddin et al . Biology . 2021; 10(11):1103. https://doi.org/10.3390/biology10111103 as evidenced by GENBANK accession no. NM_003810.2 5-23-2010 and as evidenced by NCBI Reference Sequence Accession number NP_003801 9/187/22. Fakiruddin et al disclose a mesenchymal stem cell (MSC, immune suppressor cell) transduced (modified) to include TRAIL. See title, simple summary, abstract. Fakiruddin et al disclose that MSCs expressing TRAIL (MSC-TRAIL) have antitumor properties, however, some tumors such as non-small cell lung cancer (NSCLC) are resistant to TRAIL due to the existence of cancer stem cells (CSCs). Fakiruddin et al disclose that pre-treatment using either cisplatin or 5-FU was able to increase the efficacy of MSC-TRAIL to kill the TRAIL resistant A549 derived CSCs, both 5-FU; vinorelbine were an effective chemo-sensitizer, used to increase the anti-tumor effect of MSC-TRAIL against H460-H2170 derived CSC; and pretreatment using cisplatin enhanced the effect of MSC-TRAIL in H460 derived CSC. Fakiruddin et al disclose that pretreatment using certain chemotherapies in NSCLC could enhance the antitumor effect of MSC-TRAIL to target the CSCs, and therefore the combination of chemotherapies and MSC-TRAIL may serve as a novel approach for the treatment of NSCLC. Fakiruddin et al disclose that the nucleic acid of the TRAIL is human TRAIL gene accession number NM_003810.2 which includes a nucleic acid sequence having 95% sequence identity to SEQ ID NO: 2 (see Appendix A attached) and Fakiruddin et al disclose the nucleic acid sequence is operably linked to a promoter in a lentivirus vector. See section 2.3. As evidenced by NCBI Reference Sequence accession number NP_003801 the amino acid sequence of human TRAIL comprises an amino acid sequence that is 100% identical to SEQ ID NO: 1. It would have been prima facie obvious to a person of ordinary skill in the art as of the effective filing date of the instant invention to have administered a combination of chemotherapy and MSC-TRAIL to treat TRAIL resistant NSCLC as taught by Fakiruddin et al, thus resulting in the instant invention with a reasonable expectation of success. The motivation to do so is that some tumors such as non-small cell lung cancer (NSCLC) are resistant to TRAIL due to the existence of cancer stem cells (CSCs) and Fakiruddin et al disclose that combination of certain chemotherapy and MSC-TRAIL enhance the antitumor effect of MSC-TRAIL to target the CSCs, and therefore the combination of chemotherapies and MSC-TRAIL may serve as a novel approach for the treatment of NSCLC. Status of Claims Claims 1-16 are rejected. Any inquiry concerning this communication or earlier communications from the examiner should be directed to FILLIN "Examiner name" \* MERGEFORMAT OLUWATOSIN A OGUNBIYI whose telephone number is FILLIN "Phone number" \* MERGEFORMAT (571)272-9939 . The examiner can normally be reached FILLIN "Work Schedule?" \* MERGEFORMAT IFP . 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 Daniel Kolker can be reached at FILLIN "SPE Phone?" \* MERGEFORMAT 5712723181 . 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. /OLUWATOSIN A OGUNBIYI/ Primary Examiner, Art Unit 1645
Read full office action

Prosecution Timeline

Sep 22, 2023
Application Filed
Feb 16, 2024
Response after Non-Final Action
Mar 09, 2026
Non-Final Rejection — §102, §103 (current)

Precedent Cases

Applications granted by this same examiner with similar technology

Patent 12599549
TREATMENT OF MODERATE TO VERY SEVERE GLABELLAR LINES AND LATERAL CANTHAL LINES
2y 5m to grant Granted Apr 14, 2026
Patent 12601745
DIAGNOSTICS OF PERIODONTITIS
2y 5m to grant Granted Apr 14, 2026
Patent 12594309
BIFIDOBACTERIA FOR TREATING DIABETES AND RELATED CONDITIONS
2y 5m to grant Granted Apr 07, 2026
Patent 12589124
BIFIDOBACTERIUM LONGUM
2y 5m to grant Granted Mar 31, 2026
Patent 12590285
CULTURE MEDIUM FOR BACTERIA
2y 5m to grant Granted Mar 31, 2026
Study what changed to get past this examiner. Based on 5 most recent grants.

AI Strategy Recommendation

Get an AI-powered prosecution strategy using examiner precedents, rejection analysis, and claim mapping.
Powered by AI — typically takes 5-10 seconds

Prosecution Projections

1-2
Expected OA Rounds
63%
Grant Probability
99%
With Interview (+42.9%)
3y 1m
Median Time to Grant
Low
PTA Risk
Based on 914 resolved cases by this examiner. Grant probability derived from career allow rate.

Sign in with your work email

Enter your email to receive a magic link. No password needed.

Personal email addresses (Gmail, Yahoo, etc.) are not accepted.

Free tier: 3 strategy analyses per month