Prosecution Insights
Last updated: October 02, 2026
Application No. 18/831,041

Formulated and/or Co-Formulated Nanocarrier Compositions Containing TFGß Antagonist Prodrugs Useful in the Treatment of Cancer and Methods Thereof

Final Rejection §112
Filed
May 13, 2024
Priority
Jul 10, 2023 — continuation of 18/445,323
Examiner
DAVIS, BRIAN J
Art Unit
1614
Tech Center
1600 — Biotechnology & Organic Chemistry
Assignee
Nammi Therapeutics Inc.
OA Round
2 (Final)
85%
Grant Probability
Favorable
3-4
OA Rounds
0m
Est. Remaining
81%
With Interview

Examiner Intelligence

Grants 85% — above average
85%
Career Allowance Rate
1348 granted / 1589 resolved
+24.8% vs TC avg
Minimal -4% lift
Without
With
+-4.0%
Interview Lift
resolved cases with interview
Fast prosecutor
1y 9m
Avg Prosecution
47 currently pending
Career history
1625
Total Applications
across all art units

Statute-Specific Performance

§101
5.2%
-34.8% vs TC avg
§103
16.5%
-23.5% vs TC avg
§102
19.7%
-20.3% vs TC avg
§112
44.7%
+4.7% vs TC avg
Black line = Tech Center average estimate • Based on career data from 1589 resolved cases

Office Action

§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 . Claim Objections Withdrawn The objections to claims 4, 8 and 12, outlined in the previous Office Action, have been overcome by inventor’s amendment. With respect to claims 4 and 8, the amendment cancels the claims. With respect to claim 12, the amendment corrects the claim text as appropriate. The objection to claims 11 and 23, as being dependent upon a rejected base claim but otherwise allowable, is withdrawn. With respect to claim 11, the amendment cancels the claim. With respect to claim 23, the claim is newly rejected, vide infra. Allowability Withdrawn The allowability of claims 1-3 is withdrawn in light of inventor’s amendment. With respect to claims 2 and 3, the amendment cancels the claims. With respect to claim 1, the claim is newly rejected, vide infra. 112(b) Rejections Withdrawn The rejection of claim 6 under 35 USC 112(b) or 35 USC 112 (pre-AIA ), second paragraph, outlined in the previous Office Action, has been overcome by inventor’s amendment. The amendment clarifies the claim as appropriate. The rejection of claims 7, 10, 12 and 14 under 35 USC 112(b) or 35 USC 112 (pre-AIA ), second paragraph, outlined in the previous Office Action, has been overcome by inventor’s amendment. With respect to claims 7 and 10, the amendment cancels the claims. With respect to claims 12 and 14, the amendment clarifies the claims as appropriate. The rejection of claim 15 under 35 USC 112(b) or 35 USC 112 (pre-AIA ), second paragraph, outlined in the previous Office Action, is withdrawn. This rejection should have been made for claim 20, not claim 15. The examiner regrets the error. In any case, claim 20 has been amended such that the rejection has been overcome. The rejection of claim 20 under 35 USC 112(b) or 35 USC 112 (pre-AIA ), second paragraph, outlined in the previous Office Action, has been overcome by inventor’s amendment. The amendment clarifies the claim as appropriate. The rejection of claim 13 under 35 USC 112(b) or 35 USC 112 (pre-AIA ), second paragraph, outlined in the previous Office Action (indefinite from indefinite), is withdrawn. The rejection is moot. Claim Rejections - 35 USC § 112(b), NEW 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 1 and 5 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. In claim 1, for instance, it is unclear how a composition can be said to have a chemical structure (“A TB prodrug composition having the following chemical formula: [a diagramed chemical structure].” That is, it is unclear if the claim is drawn to a composition which comprises the diagramed chemical structure, or if the claim is drawn to the diagramed chemical structure itself. Analysis of claim 5 is similar. Clarification is very much in order. Claim 9 is 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. In part (i) of the claim, it is unclear how the nanocarrier comprising a composition can be said to have a chemical structure (“…wherein the nanocarrier comprises a TB prodrug composition having the following chemical formula: [a diagramed chemical structure]….” That is, does part (i) of the claim refer to a composition, perhaps, which comprises the diagramed chemical structure? Clarification is very much in order. Claims 6 and 12-29 are also 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 claims all depend, or ultimately depend, from an indefinite claim yet do not relieve the indefiniteness. Dependent claims 6 and 12-29 are also, therefore, indefinite. 112(d) Rejections Withdrawn The rejection of claim 24 under 35 USC 112(d) or 35 USC 112 (pre-AIA ), fourth paragraph, outlined in the previous Office Action, has been overcome by inventor’s amendment. The amendment changes the dependency of the claim such that it is now in proper dependent form. Claim Rejections - 35 USC § 112(d), NEW The following is a quotation of 35 U.S.C. 112(d): (d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers. The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph: Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers. Claim 23 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, fourth paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. In the present instance, the claim fails to further limit the subject matter of the claim upon which it depends, claim 9. Claim 9 is drawn to a method. Claim 23 is drawn to a kit comprising a nanocarrier which is utilized in the method. However, defining a kit does not further limit the steps of the method. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements. Double Patenting Rejections Withdrawn The statutory double patenting rejections of claims 5 and 6, outlined in the previous Office Action, have been overcome by inventor’s amendment. The amendment rewrites the claims such that the rejections are moot. The provisional statutory double patenting rejection of claims 9 and 21, outlined in the previous Office Action, has been overcome by inventor’s submission of an acceptable Terminal Disclaimer. The provisional nonstatutory double patenting rejection of claims 10, 12-19, 21 and 22, outlined in the previous Office Action, has been overcome by inventor’s submission of an acceptable Terminal Disclaimer. (The amendment cancels claim 10.) 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 BRIAN J DAVIS whose telephone number is (571)272-0638. The examiner can normally be reached M-F 8:30-5:00 PM EDT. 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, Ali Soroush, can be reached at 571-272-9925. 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. /BRIAN J DAVIS/Primary Examiner, Art Unit 1614 8/26/2026
Read full office action

Prosecution Timeline

May 13, 2024
Application Filed
Mar 17, 2026
Non-Final Rejection mailed — §112
Jul 03, 2026
Response Filed
Aug 27, 2026
Final Rejection mailed — §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

3-4
Expected OA Rounds
85%
Grant Probability
81%
With Interview (-4.0%)
1y 9m (~0m remaining)
Median Time to Grant
Moderate
PTA Risk
Based on 1589 resolved cases by this examiner. Grant probability derived from career allowance rate.

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