Office Action Predictor
Application No. 17/291,694

COMPOUNDS AND COMPOSITIONS FOR THE TREATMENT OF RESPIRATORY DISEASES

Non-Final OA §102§112
Filed
May 06, 2021
Examiner
YOO, SUN JAE
Art Unit
1621
Tech Center
1600 — Biotechnology & Organic Chemistry
Assignee
Tianli Biotech Pty LTD
OA Round
4 (Non-Final)
71%
Grant Probability
Favorable
4-5
OA Rounds
2y 11m
To Grant
72%
With Interview

Examiner Intelligence

71%
Career Allow Rate
868 granted / 1224 resolved
Without
With
+1.0%
Interview Lift
avg trend
2y 11m
Avg Prosecution
43 pending
1267
Total Applications
career history

Statute-Specific Performance

§101
0.5%
-39.5% vs TC avg
§103
14.5%
-25.5% vs TC avg
§102
29.8%
-10.2% vs TC avg
§112
32.6%
-7.4% vs TC avg
Black line = Tech Center average estimate • Based on career data

Office Action

§102 §112
DETAILED ACTION Notice of Pre-AIA or AIA Status 1. 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 2. 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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 July 9, 2025 has been entered. Response to Amendment 3. The amendments to the claims filed on July 9, 2025 have been fully considered. The amendments are sufficient to overcome the outstanding grounds of rejection which are withdrawn. 4. Applicants have amended the claims to overcome the prior art rejection. Pursuant MPEP 803.02 the search and examination was extended. Prior art was found that anticipates the claims with respect to a nonelected species in the amended claims. For this reason, the claims were rejected and claims to nonelected species were held withdrawn from further consideration. The search was extended to the full scope of claims 12, 16 and 19, and additionally to the species shown in this office action. 5. Applicant’s amendments necessitated new grounds of rejection under 35 USC 112. Claim Rejections - 35 USC § 112 The following is a quotation of the first paragraph of 35 U.S.C. 112(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. 6. Claims 1, 4, 12, 14-19, 21, 24 and 28 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. Applicants have amended the claims to exclude the specific compound of PNG media_image1.png 106 184 media_image1.png Greyscale . This compound was not described in the disclosure. The exclusion of a species that was not described previously adds new matter to the claims. 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 applicant regards as his invention. 7. Claim 19 recites the limitation "C0-3alkylC3-7cycloalkylhalo.” There is insufficient antecedent basis for this limitation in the claim. Claim Rejections - 35 USC § 102 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. 8. Claim(s) 1, 4, 14, 15, 17, 18, 24 and 28 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by RN 2249722-90-3 ( PNG media_image2.png 196 312 media_image2.png Greyscale ). The reference has a date of November 19, 2018 which antedates the present claims having a filing date of November 7, 2019 and priority claim to foreign applications dated November 7, 2018. Priority cannot be granted to the present claims because the priority document does not provide sufficient support for the claimed genus. The present genus includes various embodiments that were not previously described. For example, at least the first compound of claim 23 and embodiments for variable R1. The prior art compound corresponds to the first compound of claim 23. Moreover, the compound corresponds to Formula I in the following manner: R1=hydroxyalkyl (C2); R2=H; R3=F; R4=C0C6 cycloalkyl. Conclusion Any inquiry concerning this communication or earlier communications from the examiner should be directed to SUN JAE YOO whose telephone number is (571)272-9074. The examiner can normally be reached Mon-Fri 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. 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. /SUN JAE YOO/Primary Examiner, Art Unit 1621
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Prosecution Timeline

May 06, 2021
Application Filed
May 06, 2021
Response after Non-Final Action
Apr 20, 2022
Response after Non-Final Action
Jun 01, 2024
Non-Final Rejection — §102, §112
Nov 06, 2024
Response Filed
Apr 07, 2025
Final Rejection — §102, §112
Jul 09, 2025
Request for Continued Examination
Jul 16, 2025
Response after Non-Final Action
Nov 24, 2025
Non-Final Rejection — §102, §112
Mar 25, 2026
Response Filed
Apr 07, 2026
Final Rejection — §102, §112 (current)

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Prosecution Projections

4-5
Expected OA Rounds
71%
Grant Probability
72%
With Interview (+1.0%)
2y 11m
Median Time to Grant
High
PTA Risk
Based on 1224 resolved cases by this examiner