Prosecution Insights
Last updated: October 27, 2026
Application No. 18/939,822

PROCESSES OF MAKING AND CRYSTALLINE FORMS OF A MDM2 INHIBITOR

Non-Final OA §DP
Filed
Nov 07, 2024
Priority
Jun 10, 2013 — provisional 61/833,196 +6 more
Examiner
O DELL, DAVID K
Art Unit
1621
Tech Center
1600 — Biotechnology & Organic Chemistry
Assignee
Amgen Inc.
OA Round
1 (Non-Final)
58%
Grant Probability
Moderate
1-2
OA Rounds
9m
Est. Remaining
94%
With Interview

Examiner Intelligence

Grants 58% of resolved cases
58%
Career Allowance Rate
778 granted / 1348 resolved
-2.3% vs TC avg
Strong +36% interview lift
Without
With
+36.0%
Interview Lift
resolved cases with interview
Typical timeline
2y 9m
Avg Prosecution
58 currently pending
Career history
1409
Total Applications
across all art units

Statute-Specific Performance

§101
1.5%
-38.5% vs TC avg
§103
34.5%
-5.5% vs TC avg
§102
14.4%
-25.6% vs TC avg
§112
30.1%
-9.9% vs TC avg
Black line = Tech Center average estimate • Based on career data from 1348 resolved cases

Office Action

§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 . DETAILED ACTION 1. Claims 13-15, 18, 39 are pending in the current application. 2. This application is a CON of 18/313,428 05/08/2023 ABN; 18/313,428 is a CON of 17/500,039 10/13/2021 ABN; 17/500,039 is a CON of 16/664,103 10/25/2019 ABN; 16/664,103 is a CON of 15/820,830 11/22/2017 ABN; 15/820,830 is a CON of 15/163,186 05/24/2016 PAT 9855259; 15/163,186 is a CON of 14/301,087 06/10/2014 PAT 9376386; 14/301,087 has PRO 61/833,196 06/10/2013. 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. 3. Claim 13-15, are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 22-28 of U.S. Patent No. 9,623,018. Although the claims at issue are not identical, they are not patentably distinct from each other because the process of claim 22 requires the process of the instant claims. The distillation with toluene would produce the salt form before forming the solvate. For these reasons the patented process could not be practiced without conducting the claimed steps. The steps of claim 23 are the same as those instant claim 15. 4. Claims 18, 39 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2, 9-10 of U.S. Patent No. 9,801,867. Although the claims at issue are not identical, they are not patentably distinct from each other because the process of claim 9 is drawn to the preparation of the compound of claim 18 through the same oxidation process and claims 1-3 describe the reaction of the napsylate with the calcium salt to generate the compound of claim 9 starting material, the first step of claim 18. The combination of the steps is implied by the process claimed. The calcium sulfinate salt of claims 1-2 would be inherently produced if the base were a calcium base. With respect to claim 39, sodium t-butoxide is a well-known strong base and would be expected to effectively generate an anion from the sulfinic acid. Conclusion 5. Any inquiry concerning this communication or earlier communications from the examiner should be directed to DAVID K O'DELL whose telephone number is (571)272-9071. The examiner can normally be reached on Monday - Friday 9:30 - 7:00 PM. If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Clinton Brooks can be reached on 571-270-7682. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300. Information regarding the status of an application may be obtained from Patent Center. Status information for published applications may be obtained from Patent Center. Status information for unpublished applications is available through Patent Center for authorized users only. Should you have questions about access to Patent Center, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). 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) Form at https://www.uspto.gov/patents/uspto-automated- interview-request-air-form. /DAVID K O'DELL/Primary Examiner, Art Unit 1621
Read full office action

Prosecution Timeline

Nov 07, 2024
Application Filed
Sep 21, 2026
Non-Final Rejection mailed — §DP (current)

Precedent Cases

Applications granted by this same examiner with similar technology

Patent 12767983
Asymmetric Rhodamine Dye and Use Thereof in Biological Assays
5y 4m to grant Granted Oct 20, 2026
Patent 12760051
METHOD FOR PRODUCING OPTICALLY ACTIVE COMPOUND
3y 9m to grant Granted Oct 13, 2026
Patent 12760049
METAL-ASSISTED DELAYED FLUORESCENT EMITTERS EMPLOYING PYRIDO-PYRROLO-ACRIDINE AND ANALOGUES
3y 4m to grant Granted Oct 13, 2026
Patent 12753146
INDUSTRIAL SYNTHESIS OF SERINOL
3y 0m to grant Granted Oct 06, 2026
Patent 12747207
TEAD INHIBITORS
2y 11m to grant Granted Sep 29, 2026
Study what changed to get past this examiner. Based on 5 most recent grants.

Strategy Recommendation AI-generated — please review before filing

Get a prosecution strategy drawn from examiner precedents, rejection analysis, and claim mapping.
Typically takes 5-10 seconds — AI-generated, attorney review required before filing

Prosecution Projections

1-2
Expected OA Rounds
58%
Grant Probability
94%
With Interview (+36.0%)
2y 9m (~9m remaining)
Median Time to Grant
Low
PTA Risk
Based on 1348 resolved cases by this examiner. Grant probability derived from career allowance rate.

Sign in with your work email

Enter your email to receive a magic link. No password needed.

Personal email addresses (Gmail, Yahoo, etc.) are not accepted.

Free tier: 3 strategy analyses per month