Prosecution Insights
Last updated: April 19, 2026
Application No. 18/058,441

SYNTHESIS OF HALICHONDRINS

Non-Final OA §112§DP
Filed
Nov 23, 2022
Examiner
OH, TAYLOR V
Art Unit
1625
Tech Center
1600 — Biotechnology & Organic Chemistry
Assignee
Eisai R&D Management Co. Ltd.
OA Round
1 (Non-Final)
81%
Grant Probability
Favorable
1-2
OA Rounds
2y 5m
To Grant
96%
With Interview

Examiner Intelligence

Grants 81% — above average
81%
Career Allow Rate
1415 granted / 1742 resolved
+21.2% vs TC avg
Strong +15% interview lift
Without
With
+15.3%
Interview Lift
resolved cases with interview
Typical timeline
2y 5m
Avg Prosecution
35 currently pending
Career history
1777
Total Applications
across all art units

Statute-Specific Performance

§101
0.4%
-39.6% vs TC avg
§103
33.6%
-6.4% vs TC avg
§102
19.5%
-20.5% vs TC avg
§112
37.3%
-2.7% vs TC avg
Black line = Tech Center average estimate • Based on career data from 1742 resolved cases

Office Action

§112 §DP
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 . Non-Final Rejection The Status of Claims: Claims 582-602 are pending. Claims 582-583, 586-588, and 595-596 are rejected. Claims 584-585, 589-602 are withdrawn from consideration. DETAILED ACTION Claims 582-583, 586-588, and 595-596 are under consideration in this Office Action. Priority It is noted that this application is a division of 16628504 01/03/2020 ( PAT 11548898), which is a 371 of PCT/US2018/041005 07/06/2018, which claims benefit of 62/529,333 07/06/2017 and claims benefit of 62/529,310 07/06/2017. Drawings 3. The drawings filed on 11/23/22 are accepted by the examiner. IDS 4. The IDS filed on 2/03/26, 3/22/23, 2/23/23 have been reviewed by the examiner. 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 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/Restriction Applicant’s election with traverse of Group VI (Claims 595-596 ) with a request for rejoining Group I (Claims 582-583, 586-588) together for the examination on 2/03/26 is acknowledged. Claims 584-585, 589-602 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to nonelected groups II-V, and VII-IX, there being no allowable generic or linking claim. Applicants argue in the followings: Applicant respectfully submits that the search and examination of Group I and Group VI can be made together without serious burden. "If the search and examination of all the claims in an application can be made without serious burden, the examiner must examine them on the merits, even though they include claims to independent or distinct inventions." MPEP § 803. The claims f Group I are directed to methods of preparing compounds of Formula (H3-2-I) and salts thereof, and the claims Group VI are directed to said compounds of Formula (H3-2-I) and salts thereof. Therefore, Applicant submits that search and examination of the claims can be made together without serious burden, at least with respect to Groups I and VI. Accordingly, Applicant respectfully requests that the Restriction Requirement be withdrawn between said groups. Regarding applicants’ arguments, the examiner has considered applicant’s ‘views. They are persuasive and the examiner has decided to rejoin Groups I and VI together for the examination of the claims. The Elected Species: The elected species is in the following: PNG media_image1.png 215 491 media_image1.png Greyscale , which is found to be not allowable at this time in view of claim 13 of U.S. Patent No.11,814,398. 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. Claims 582-583, 586-588 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 pre-AIA the applicant regards as the invention. In claim 582, the phrase” comprising cyclizing a compound of Formula (H3-2-II)” are recited. This expression is vague and indefinite because the claim does not specify what kind of reagent(s) and catalyst are involved in the process of cyclizing Compound (H3-2-II). The examiner recommends to put the specific reagent(s) and any condition(s) into the claim. In claim 583, the phrase” comprising coupling a compound of Formula (L-2- 6) with a compound of Formula (R-2-I)” is recited. This expression is vague and indefinite because the claim does not specify what kind of reagent(s) and any catalyst are involved in the coupling process of a compound of Formula (L-2- 6) with “a compound of Formula (R-2-1)”. the examiner recommends to put the specific reagents and any catalyst into the claim. In claim 586, the phrase” comprising cyclizing Compound (C)” is recited. This expression is vague and indefinite because the claim does not specify what kind of reagent(s) and catalyst are involved in the process of cyclizing Compound (C)”. The examiner recommends to put the specific reagent(s) and any condition(s) into the claim. In claim 587, the phrase” coupling a compound of Formula (E-L) with a compound of Formula (E-R)” is recited. This expression is vague and indefinite because the claim does not specify what kind of reagent(s) and any catalyst are involved in the coupling process with “a compound of Formula (E-R)”. the examiner recommends to put the specific reagents and any catalyst into the claim. In claim 588, the phrase” a step of deprotecting a compound of Formula (E-1)”. This expression is vague and indefinite because the claim does not specify what kind of a reagent are involved in the deprotecting step of a compound of Formula (E-1). The examiner recommends to put the specific reagent into the claims. 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 claims at issue 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); and 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 a nonstatutory double patenting ground provided the reference application or patent either is shown to be commonly owned with this application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b). The USPTO internet Web site contains terminal disclaimer forms which may be used. Please visit http://www.uspto.gov/forms/. The filing date of the application will determine what form 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 http://www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp. Claims 595-596 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 13 of U.S. Patent No. 11,814,398. Although the claims at issue are not identical, they are not patentably distinct from each other because the scope of the claimed invention is overlapped with that of U.S. Patent No.. The claim 1 and 13 of U.S. Patent No. 11,814,398 describe the followings: 1 PNG media_image2.png 387 389 media_image2.png Greyscale PNG media_image3.png 228 334 media_image3.png Greyscale PNG media_image4.png 295 572 media_image4.png Greyscale , whereas the instant claims 595-596 do disclose the following method as shown below: PNG media_image5.png 394 904 media_image5.png Greyscale PNG media_image6.png 424 757 media_image6.png Greyscale PNG media_image7.png 297 682 media_image7.png Greyscale However, the instant claims differ from the U.S. Patent No. 11,814,398 in that the scope of the claimed invention with respect to the variables around the common core structure is slightly broader than that of the U.S. Patent No. . Even so, the specification does disclose the same compound as the elected species (claim 596) as shown below: PNG media_image8.png 426 804 media_image8.png Greyscale (see cols. 125-126). . From this, it seems reasonable that the limitation of the compound (D-5) can be incorporated into the claim 13 in order to emphasize the particular compound of the claimed invention. Moreover, such a limitation can be anticipated; there is very little difference as to the patentable distinction. So, it would have been obvious to the skilled artisan to be motivated to add that limitation to the claim in order to achieve the similar or same scope of the claimed invention. This is because the skilled artisan in the art would expect such a manipulation to be feasible and successful as guidance shown in the application. Conclusion Claims 582-583, 586-588, and 595-596 are rejected. Claims 584-585, 589-602 are withdrawn from consideration. Any inquiry concerning this communication or earlier communications from the examiner should be directed to TAYLOR V OH whose telephone number is (571)272-0689. The examiner can normally be reached 8:00-5:00. 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 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. /TAYLOR V OH/Primary Examiner, Art Unit 1625 3/7/2026
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Prosecution Timeline

Nov 23, 2022
Application Filed
Mar 07, 2026
Non-Final Rejection — §112, §DP (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

1-2
Expected OA Rounds
81%
Grant Probability
96%
With Interview (+15.3%)
2y 5m
Median Time to Grant
Low
PTA Risk
Based on 1742 resolved cases by this examiner. Grant probability derived from career allow rate.

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