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 .
Election/Restrictions
Applicant's election with traverse of group I and compound
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in the reply filed on July 28, 2026 is acknowledged. The traversal is on the ground(s) that claims drawn to a product and process in a national stage application have unity of invention and should be searched and examined together and the compounds of the claims share the same core structure. This is not found persuasive because the lack of unity determination was not based on the compounds not sharing a common core but as set forth on p 5 of the Restriction Requirement mailed May 13, 2026, that the common technical feature between groups I and II is not a special technical feature in view of Gibbs et al. (WO 2020/033435) and therefore unity of invention is not present.
The requirement is still deemed proper and is therefore made FINAL.
The elected species compound is free of the prior art. Therefore the search and examination was expanded to
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.
Information Disclosure Statement
The information disclosure statement filed April 9, 2025 fails to comply with the provisions of 37 CFR 1.98(a)(4) because it lacks the appropriate size fee assertion. It has been placed in the application file, but the information referred to therein has not been considered as to the merits.
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.
Claim(s) 1, 12 and 13 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Gibbs et al. (WO 2020/033435, cited on IDS filed December 28, 2023).
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is disclosed at ¶ [0043] and reads on formula (I) with R2 = R3 = ethyl and R1 = X1, with X1 = C2 straight alkyl. In ¶ [0403], a composition comprising LGW01-08 and phosphate buffered saline (PBS) was prepared, reading on the compositions of claims 12 and 13 since PBS is pharmaceutically acceptable carrier or excipient.
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, 12 and 13 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 2 and 6 - 9 of U.S. Patent No. 11,492,359. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of US’359 recite compounds falling within the scope of the instant claims. Compounds of formula I(e) with R3a and R3b being a C1-C4 alkyl; R7 being C1-C4 alkyl; and R8a and R8b being hydrogen or C1-C4 alkyl where are least one of R8a and R8b must not be hydrogen render obvious the compounds of instant claim 1. The compounds can also be used in a method of imaging a target area in a subject by contact that target area with the compound such as by systemic administration (claims 6 – 9). One of ordinary skill in the art would understand that such as administration route requires a pharmaceutically acceptable carrier or excipient such as a buffered saline based on their knowledge.
Claims 1, 12 and 13 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 - 16 of copending Application No. 17/790,698 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the compounds of US’698 recite compounds falling within the scope of the instant claims as the definitions of R (R1 of the instant claims) and R1 and R2 (R2 and R3 of the instant claims) overlap such that claims of US’698 and the instant claims are not patentably distinguished from over another. Claims 14 and 16 recite compositions of the claimed compounds with a pharmaceutically acceptable carrier or excipient. One of ordinary skill in the art would such pharmaceutically acceptable carrier or excipients include buffered saline based on their knowledge.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Nissa M Westerberg whose telephone number is (571)270-3532. The examiner can normally be reached M - F 8 am - 4 pm.
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, Michael Hartley can be reached at 571-272-0616. 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.
/Nissa M Westerberg/Primary Examiner, Art Unit 1618
Prosecution Insights