Prosecution Insights
Last updated: August 06, 2026
Application No. 18/774,321

IMMUNOREGULATORY COMPOUNDS

Final Rejection §103
Filed
Jul 16, 2024
Priority
Dec 20, 2021 — provisional 63/291,891 +1 more
Examiner
ROBINSON, MIKHAIL O'DONNEL
Art Unit
1627
Tech Center
1600 — Biotechnology & Organic Chemistry
Assignee
Nimml Institute
OA Round
2 (Final)
59%
Grant Probability
Moderate
3-4
OA Rounds
1y 3m
Est. Remaining
99%
With Interview

Examiner Intelligence

Grants 59% of resolved cases
59%
Career Allowance Rate
73 granted / 124 resolved
-1.1% vs TC avg
Strong +42% interview lift
Without
With
+41.5%
Interview Lift
resolved cases with interview
Typical timeline
3y 4m
Avg Prosecution
44 currently pending
Career history
160
Total Applications
across all art units

Statute-Specific Performance

§101
5.2%
-34.8% vs TC avg
§103
40.8%
+0.8% vs TC avg
§102
22.2%
-17.8% vs TC avg
§112
22.1%
-17.9% vs TC avg
Black line = Tech Center average estimate • Based on career data from 124 resolved cases

Office Action

§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 . Response to Arguments Applicant’s arguments, see Page 1, filed 05/16/2026, with respect to the rejection(s) of claims 30-31, 33 and 35-37 under Hebert et al. Synthesis of Highly Functionalized Triarylbismuthines by Functional Group Manipulation and Use in Palladium- and Copper-Catalyzed Arylation Reactions, JOC, May 2016, Pages 5401-5416 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. Applicants’ argument with respect to the 103 rejection of claims 1-2, 4, 6-7, 9, 12 and 16 over Zhang et al. (CN 113754591 A) is rendered moot to claims 1, 4, 6-7, 9, 12 and 16 and persuasive with respect to claim 2. Applicant argues claim 1 has been amended to not have a NH at position A1, nevertheless per claim 1 A1 can be NR4 wherein R4 can be H, thus NH can be an option for position A1. Applicants’ argument with respect to the 103 rejection of claims 20-24 and 27-29 over Stansfield et al. (US 20200109129 A1) is rendered moot to claims 20, 22-24 and 27-29 and persuasive with respect to claim 21. The reasoning of A1 as stated above for the inclusion of NH. Applicant has overcome the double patenting rejection of claims 1-2, 4-9, 12, 16 and 20-39 over U.S Patent No. 12145921 by the filing of a terminal disclaimer over U.S ‘921. Applicant has amended claim 1. Claims 1-2, 4-9, 12, 16 and 20-39 are pending. Claims 1-2, 4-9, 12, 16 and 20-39 is now evaluated on its merits. 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. Claims 1, 4, 6-7, 9, 12, 16, are rejected under 35 U.S.C. 103 as being unpatentable over Zhang et al. (CN 113754591 A). Regarding claims 1, 4, 6-7, 9, 12 and 16, Zhang teaches a method to treat or reduce tumor severity of diseases of inflammation, autoimmune, melanoma, multiple myeloma, skin T cell lymphoma, human erythrocyte leukemia, human chronic myelocytic leukemia, breast cancer, pancreatic cancer, gastric cancer, lung cancer, colorectal cancer, colon cancer and prostate cancer (relevant to claims 12 and 16) comprising administration of compound formula (I) PNG media_image1.png 87 187 media_image1.png Greyscale , in which R1 is hydrogen, R2 is six-membered aryl, para-substituted six-membered aryl, six-membered heteroaryl, para-substituted six-membered heteroaryl and X is structure PNG media_image2.png 66 118 media_image2.png Greyscale (page 2, para. 1). The compound is further represented by compound 10b PNG media_image3.png 104 244 media_image3.png Greyscale (para. and compound 33 PNG media_image4.png 127 271 media_image4.png Greyscale (para. 0038). These structures read to limitations of claims 1, 4, 6-7 and 9 of A1 being NH (relevant to claim 2), A3 as N (relevant to claim 4), A5 as CH (relevant to claim 6), R1 as H and Cl (relevant to claim 7), R2 as substituted amine and R3 as COOH and COOCH2CH3 (relevant to claim 9). Zhang et al. does not teach the positions of R1-R3 of the claimed invention represented in compounds 10b and 33. Therefore, it would have been obvious to someone of ordinary skill in the art at the time of filing to have used the composition of 10b and 33 taught by Zhang to treat or reduce tumor severity of an inflammatory disease. One would have been motivated to do so because the positions of R1- R2 and Y of the above compound examples taught by Zhang et al. are position isomers in respect to R1-R3 of claimed compound, hence therefore would possess similar properties of the claimed compound as per MPEP 2144.09 (II): “Compounds which are position isomers (compounds having the same radicals in physically different positions on the same nucleus) or homologs (compounds differing regularly by the successive addition of the same chemical group, e.g., by -CH2- groups) are generally of sufficiently close structural similarity that there is a presumed expectation that such compounds possess similar properties. In re Wilder, 563 F.2d 457, 195 USPQ 426 (CCPA 1977)”. There would be a reasonable expectation of success with the positional isomer compounds taught by Zhang et al. having the similar structural properties of claimed compound to treat or reduce tumor severity of an inflammatory disease. Claims 20, 22-24 and 27-29 are rejected under 35 U.S.C. 103 as being unpatentable over Stansfield et al. (US 20200109129 A1). Regarding claims 20, 22-24 and 27-29, Stansfield et al. teaches pharmaceutical compounds for therapy or prophylaxis in mammals for treatment of diseases such as cancer, inflammatory disorders, metabolic disorders and autoimmune disorders (relevant to claims 28-29) (abstract) exhibited by compound 84 (pg.276) PNG media_image5.png 332 464 media_image5.png Greyscale which reads to the limitations of A1 as NH, A2 as N, A3 as N, A4 as CHCH3, A5 as N, and R3 as CON(CH3)2 (relevant to claims 20, 22-24 and 27). Stansfield et al. does not teach the positions of A4-A5 and R3 of the claimed invention represented in compound 84. Therefore, it would have been obvious to someone of ordinary skill in the art at the time of filing to have to have used the compound taught Stansfield et al. because the positions of A4, A5 and R3, on the compound taught by Stansfield et al. are of positional isomers to the claimed invention, hence therefore would possess similar properties of the claimed compound as per MPEP 2144.09 (II): “Compounds which are position isomers (compounds having the same radicals in physically different positions on the same nucleus) or homologs (compounds differing regularly by the successive addition of the same chemical group, e.g., by -CH2- groups) are generally of sufficiently close structural similarity that there is a presumed expectation that such compounds possess similar properties. In re Wilder, 563 F.2d 457, 195 USPQ 426 (CCPA 1977)”. There would be a reasonable expectation of the claimed compound and compound 84 have similar structural properties to treat an inflammatory disease. Allowable Subject Matter Claims 2, 5, 8, 21 and 25-26 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims. Claims 30-39 are free of the arts. Conclusion Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 nonprovisional extension fee (37 CFR 1.17(a)) 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 MIKHAIL O'DONNEL ROBINSON whose telephone number is (571)270-0777. The examiner can normally be reached Monday-Friday 7:30am-5:30pm. 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, Kortney Klinkel can be reached at 571-270-5239. 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. MIKHAIL O'DONNEL. ROBINSON Examiner Art Unit 1627 /MIKHAIL O'DONNEL ROBINSON/Examiner, Art Unit 1627 /SARAH PIHONAK/Primary Examiner, Art Unit 1627
Read full office action

Prosecution Timeline

Jul 16, 2024
Application Filed
Apr 21, 2026
Non-Final Rejection mailed — §103
May 16, 2026
Response Filed
Jul 31, 2026
Final Rejection mailed — §103 (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

3-4
Expected OA Rounds
59%
Grant Probability
99%
With Interview (+41.5%)
3y 4m (~1y 3m remaining)
Median Time to Grant
Moderate
PTA Risk
Based on 124 resolved cases by this examiner. Grant probability derived from career allowance rate.

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