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 .
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.
Election/Restrictions
Applicant’s election without traverse in the reply filed on 15 April 2026, is acknowledged.
Applicants provided a compliant species:
PNG
media_image1.png
280
274
media_image1.png
Greyscale
of genus formula II of instant claims 1 and 13, wherein: T1 is-CH-; R1 is
PNG
media_image2.png
76
46
media_image2.png
Greyscale
; Ra is methoxy; and R4 is -Cl.
The elected species is free of the prior art.
The Examiner extended the Markush search to the full scope of instant claims 1 and 13 but did not find any prior art.
Therefore, the Election of Species Requirement of 11 February 2026, is withdrawn, as all claims are free of the prior art.
All claims have been examined on the merits.
Current Status of 18/559,968
This Office Action is responsive to the amended claims of 15 April 2026.
Claims 1-2, 4, and 10-16 have been examined on the merits. Claims 1-2, 10, and 13-16 are currently amended. Claims 4 and 11 are original. Claim 12 is previously presented.
Priority
The instant application’s effective filing date is 10 May 2022.
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 28 February 2024; 19 February 2025; 26 June 2025; and 10 April 2026, are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-2 and 10-16 are provisionally rejected on the ground of anticipatory nonstatutory double patenting as being unpatentable over claims 1-5, 7-9, and 11-17 of co-pending Application No. 19/127,420 (reference application). The reference amended claims of 6 May 2025 and the instant amended claims of 15 April 2026.
Although the claims at issue are not identical, they are not patentably distinct from each other because the reference claims anticipate the instant claims. For example, the reference claim 1’s species:
PNG
media_image3.png
258
208
media_image3.png
Greyscale
, anticipates instant claims 1-2 and 10-15 genus formula II, wherein: T1 is -CH-; R1 is
PNG
media_image2.png
76
46
media_image2.png
Greyscale
, which is optionally substituted with one methoxy at Ra; and R4 is -Cl (halogen).
The reference claim 17 anticipates instant claim 16, drawn to same.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
Claim 4 is 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 1-2 and 10-16 are not presently allowable as written.
There is no known prior art reference that either teaches or anticipates a compound of genus formula II of instant claims 1 and 13.
The prior art search only retrieved two hits in HCaplus of STN: the instant application, and a reference WO 2024099361 A1, provided by Applicants, which was published after the instant application’s effective filing date of 10 May 2022.
The reference CN 103796989 A discloses the compound 24:
PNG
media_image4.png
366
364
media_image4.png
Greyscale
and discloses that this compound is used to treat or prevent nephropathy (claim 1, description, para [0071] and [0079], and description, pages 111 and 113, per the Written Opinion of PCT/CN2022/092034).
However, the cyclobutyl at the locate afforded instant R1 is not an obvious variant of the bridged cyclobutyl at the instant R1.
Also, there is no genus structure within CN ‘989 with alternative species containing the instant application’s -CH2- bridged cyclobutyl at instant R1 with which to argue obviousness.
Furthermore, there is no known rationale (and no known prior art reference providing said rationale) that would support a motivation to modify the above to arrive at the instant application.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JOHN S KENYON whose telephone number is (571)270-1567. The examiner can normally be reached Monday-Friday 10a-6p.
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, Andrew D Kosar can be reached at (571) 272-0913. 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.
/JOHN S KENYON/Primary Patent Examiner, Art Unit 1625
Prosecution Insights