BICYCLIC SUBSTITUTED AROMATIC CARBOXYLIC ACID COMPOUNDS

§102 §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 . Priority The present application claims priority to the applications, CN 2021/10412189.5 and PCT/CN2022/087226, with the effective filing dates of 16 April 2021 and 15 April 2022, respectively. Claim Status This Office Action is in response to Applicant’s Amendment filed, 23 July 2026, wherein Applicant amended claims 1-2, 5, and 12-15, canceled claim 20, and added new claim 21. Claims 3, 7, 9, and 17-20 were previously withdrawn. Support for the R2 and R3 or alternatively R2 and R4 amendments to claims 1-2 can be found on pages 12-13 and 16-17 of the specification. Support for the salt amendments to claims 2, 13 and 15 can be found on pages 23-24 of the specification. Support for the halogen amendment to claim 5 can be found on page 35 of the specification. Support for the claim expression and consistency of claims 12-15 can be found in the original claims. Support for new claim 21 can be found on page 35 of the specification and in original claims 14-15. Applicant previously elected Group I and the compound, PNG media_image1.png 144 141 media_image1.png Greyscale , in the response to restriction requirement filed 25 March 2026. Applicant amended claims 12-15 to remove PNG media_image1.png 144 141 media_image1.png Greyscale and thus claims 12-15 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim. Additionally, new claim 21 is withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim. Claim 21 recites the following structures: PNG media_image2.png 336 472 media_image2.png Greyscale , which does not read on the elected species. Claims 1-2, 4-6, 8, and 10-11 are under consideration in the instant office action. Rejections Withdrawn Claim Objections 1. Claims 13-15 were objected to for the informalities of lack of comma and/or conjunction to separate the options. Claims 13-15 were amended to recite commas and conjunctions as appropriate. The Examiner also notes that claims 13-15 are now withdrawn for being directed to a nonelected species. Accordingly, the objection of claims 13-15 is withdrawn. Claim Rejections – 35 U.S.C. § 112 2. Claims 1-2 were rejected as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor regards as the invention. Applicant amended claims 1-2 to recite R2 and R3, or alternatively R2 and R4, together with an atom linked to R2 and R3, or alternatively, to R2 and R4 form a 3-6-membered heterocyclyl. Accordingly, the rejection of claims 1-2 is withdrawn. Rejections New/Modified/Maintained Claim Rejections – 35 U.S.C. § 102 3. (New) Claims 1-2, 4-6, 8, and 10-11* are rejected as being unpatentable under 35 U.S.C. 103 over Li* (WO 2022/143845, filed 30 Dec 2020, citations to the foreign priority document, CN 2020/116091415.0 (also provided for clarity)). *While Applicant elected a compound of Formula (I) ( PNG media_image1.png 144 141 media_image1.png Greyscale ), Li applies to the broader genus, and thus the rejection over the broader genus is made in favor of compact prosecution. However, the Examiner notes that the full genus was not searched. Li teaches the compounds: PNG media_image3.png 599 654 media_image3.png Greyscale (Table A, page 5 of CN 2020/11609415.0). The compound, PNG media_image4.png 179 178 media_image4.png Greyscale , falls into Formula (I). Mapping shown below: 18/286,326 Formula (I) Components 18/286,326 Formula (I) Li T1 CH PNG media_image5.png 59 84 media_image5.png Greyscale T2 CH PNG media_image5.png 59 84 media_image5.png Greyscale R1 C1-3 alkoxy (OMe) PNG media_image6.png 60 100 media_image6.png Greyscale R5 C1-3 alkoxy (OEt) PNG media_image7.png 76 79 media_image7.png Greyscale R2, R2 3-6 membered heterocyclyl (pyrrolidine) PNG media_image7.png 76 79 media_image7.png Greyscale R4 H PNG media_image7.png 76 79 media_image7.png Greyscale (R6)n n = 0 PNG media_image5.png 59 84 media_image5.png Greyscale Accordingly, Li teaches a compound of Formula (I). Regarding claim 1, Li teaches PNG media_image4.png 179 178 media_image4.png Greyscale (Table A, page 5 of CN 2020/11609415.0), wherein T1 and T2 are CH, R1 is methoxy, R2 and R3 form a pyrrolidine, R4 is H, R5 is ethoxy, and n is 0. Regarding claim 2, Li teaches that Compounds 1 and 2 ( PNG media_image8.png 164 252 media_image8.png Greyscale ) were purified via reverse phase HPLC with bicarbonate radical (page 29-30), wherein the inorganic acid is bicarbonate radical. Regarding claim 4, Li teaches PNG media_image4.png 179 178 media_image4.png Greyscale (Table A, page 5 of CN 2020/11609415.0), wherein T1 and T2 are CH, R1 is methoxy. Regarding claim 5, Li teaches PNG media_image4.png 179 178 media_image4.png Greyscale (Table A, page 5 of CN 2020/11609415.0), wherein R5 is ethoxy. Regarding claim 6, Li teaches PNG media_image4.png 179 178 media_image4.png Greyscale (Table A, page 5 of CN 2020/11609415.0), wherein R2 and R3 form a pyrrolidine (aza-cyclopentyl). Regarding claim 8, Li teaches PNG media_image4.png 179 178 media_image4.png Greyscale (Table A, page 5 of CN 2020/11609415.0), wherein the structural unit is PNG media_image9.png 80 71 media_image9.png Greyscale . Regarding claim 10, Li teaches PNG media_image4.png 179 178 media_image4.png Greyscale (Table A, page 5 of CN 2020/11609415.0), wherein the structural unit is PNG media_image10.png 48 73 media_image10.png Greyscale . Regarding claim 11, Li teaches PNG media_image4.png 179 178 media_image4.png Greyscale (Table A, page 5 of CN 2020/11609415.0), wherein the compound is PNG media_image11.png 171 144 media_image11.png Greyscale . Claim Rejections – 35 U.S.C. § 103 4. (Modified) Claims 1-2, 4-6, 8, and 10-15 were rejected as being unpatentable under 35 U.S.C. 103 over Li (WO 2022/143845, filed 30 Dec 2020, citations to the foreign priority document, CN 2020/116091415.0 (also provided for clarity)). Claims 12-15 are now withdrawn for being directed to a nonelected species. Accordingly, claims 1-2, 4-6, 8, and 10-11 are rejected as being unpatentable under 35 U.S.C. 103 over Li (WO 2022/143845, filed 30 Dec 2020, citations to the foreign priority document, CN 2020/116091415.0 (also provided for clarity)). *The Examiner notes that Li was previously cited with the filing date of 31 Dec 2021, but Li has support for the compound PNG media_image4.png 179 178 media_image4.png Greyscale (page 5, 9-10, and 27) in the priority document, CN 2020/11609415.0, filed 30 Dec 2020. Accordingly, Li is no longer an intervening reference and has the effective filing date of 30 Dec 2020. Applicant’s amendment and submission, see pages 1, 4-5, 8-16, 21, and 23, have been fully considered but they are not persuasive. Applicant submitted an English language translation of the priority application (CN 2021/10412189.5, filed 16 Apr 2021). In response to Applicant’s amendment and submission, the Examiner notes that Li has support for the compound PNG media_image4.png 179 178 media_image4.png Greyscale and for the following stereoisomers: PNG media_image12.png 180 305 media_image12.png Greyscale and PNG media_image13.png 320 505 media_image13.png Greyscale (page 5, 9-10, and 27). Additionally, the Examiner notes that Li teaches that Compounds 1 and 2 ( PNG media_image8.png 164 252 media_image8.png Greyscale ) were purified via reverse phase HPLC with bicarbonate radical (page 29-30), wherein the inorganic acid is bicarbonate radical, which reads on amended claim 2. Accordingly, the rejection of claims 1-2, 4-6, 8, and 10-11 as being unpatentable over Li is maintained. Claim Rejections – Nonstatutory Double Patenting 5. (Modified) Claims 1-2, 4-6, 8, and 10-15 were rejected on the grounds of nonstatutory double patenting over claims 1 and 12-13 of 19/106,366. Claims 12-15 are now withdrawn for being directed to a nonelected species. Accordingly, claims 1-2, 4-6, 8, and 10-11 are rejected on the grounds of nonstatutory double patenting over claims 1 and 12-13 of 19/106,366. Applicant’s amendment and submission, see pages 1, 4-5, 8-16, 21, and 24, have been fully considered but they are not persuasive. Applicant submitted an English language translation of the priority application (CN 2021/10412189.5, filed 16 Apr 2021) to overcome the 103 rejection of record. Applicant then asserts that because the 112 and 103 issues of records have been rectified and thus only the provisional NSDP rejection remains and that the instant application has an earlier patent term filing date compared to the reference application, 366. In response to Applicant’s amendment and submission, the Examiner notes that the 103 rejection of record is not withdrawn, and thus the rejection on the grounds of nonstatutory double patenting cannot be withdrawn either. Accordingly, the rejection of claims 1-2, 4-6, 8, and 10-11 on the grounds of nonstatutory double patenting in view is maintained. Conclusion No claim is allowed. Any inquiry concerning this communication or earlier communications from the examiner should be directed to Madeline M Dekarske whose telephone number is (571)272-1789. The examiner can normally be reached Monday - Thursday 10am - 4pm. 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, James Alstrum-Acevedo can be reached at 571-272-5548. 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. /MADELINE M. DEKARSKE/Examiner, Art Unit 1622 /JAMES H ALSTRUM-ACEVEDO/Supervisory Patent Examiner, Art Unit 1622