Prosecution Insights
Last updated: April 19, 2026
Application No. 18/367,118

METHOD FOR IMPROVING THE PHARMACEUTIC PROPERTIES OF MICROPARTICLES COMPRISING DIKETOPIPERAZINE AND AN ACTIVE AGENT

Non-Final OA §DP
Filed
Sep 12, 2023
Examiner
WEBB, WALTER E
Art Unit
1612
Tech Center
1600 — Biotechnology & Organic Chemistry
Assignee
Mannkind Corporation
OA Round
1 (Non-Final)
46%
Grant Probability
Moderate
1-2
OA Rounds
3y 0m
To Grant
66%
With Interview

Examiner Intelligence

Grants 46% of resolved cases
46%
Career Allow Rate
454 granted / 977 resolved
-13.5% vs TC avg
Strong +19% interview lift
Without
With
+19.0%
Interview Lift
resolved cases with interview
Typical timeline
3y 0m
Avg Prosecution
60 currently pending
Career history
1037
Total Applications
across all art units

Statute-Specific Performance

§101
0.4%
-39.6% vs TC avg
§103
48.3%
+8.3% vs TC avg
§102
18.8%
-21.2% vs TC avg
§112
15.4%
-24.6% vs TC avg
Black line = Tech Center average estimate • Based on career data from 977 resolved cases

Office Action

§DP
DETAILED ACTION Notice of Pre-AIA or AIA Status The present application is being examined under the pre-AIA first to invent provisions. Nonstatutory Obvious-type 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 obviousness-type 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); 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 conflicting 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. Effective January 1, 1994, a registered attorney or agent of record may sign a terminal disclaimer. A terminal disclaimer signed by the assignee must fully comply with 37 CFR 3.73(b). 1) Claims 1-10 are rejected on the ground of nonstatutory double patenting a s being unpatentable over claim s 1-15 of U.S. Patent No. 8,039,431 . Although the claims at issue are not identical, they are not patentably distinct from each other because both claim a method of making powders of diketopoperazine loaded with an active agent, e.g., insulin . 2) Claims 1-10 are rejected on the ground of nonstatutory double patenting a s being unpatentable over claims 1-25 of U.S. Patent No. 8,512,932 . Although the claims at issue are not identical, they are not patentably distinct from each other because both claim a method of making powders of diketopoperazine loaded with an active agent, e.g., insulin . 3 ) Claims 1-10 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1- 24 of U.S. Patent No. 9,241,903 . Although the claims at issue are not identical, they are not patentably distinct from each other because both claim a method of making powders of diketopoperazine loaded with an active agent, e.g., insulin. 4 ) Claims 1-10 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-1 4 of U.S. Patent No. 10,130,581 . Although the claims at issue are not identical, they are not patentably distinct from each other because both claim a method of making powders of diketopoperazine loaded with an active agent, e.g., insulin. 5 ) Claims 1-10 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1- 6 of U.S. Patent No. 10,376,466 . Although the claims at issue are not identical, they are not patentably distinct from each other because both claim a method of making powders of diketopoperazine loaded with an active agent, e.g., insulin. 6 ) Claims 1-10 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-1 3 of U.S. Patent No. 7,820,676 . Although the claims at issue are not identical, they are not patentably distinct from each other because both claim a method of making powders of diketopoperazine loaded with an active agent, e.g., insulin. 7 ) Claims 1-10 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1- 9 of U.S. Patent No. 11,192,862 . Although the claims at issue are not identical, they are not patentably distinct from each other because both claim a method of making powders of diketopoperazine loaded with an active agent, e.g., insulin. 8 ) Claims 1-10 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-1 1 of U.S. Patent No. 10,745,359 . Although the claims at issue are not identical, they are not patentably distinct from each other because both claim a method of making powders of diketopoperazine loaded with an active agent, e.g., insulin. 9 ) Claims 1-10 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1- 2 1 of U.S. Patent No. 10,421,729 . Although the claims at issue are not identical, they are not patentably distinct from each other because both claim a method of making powders of diketopoperazine loaded with an active agent, e.g., insulin. 1 0 ) Claims 1-10 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-1 4 of U.S. Patent No. 9,675,674 . Although the claims at issue are not identical, they are not patentably distinct from each other because both claim a method of making powders of diketopoperazine loaded with an active agent, e.g., insulin. 1 1 ) Claims 1-10 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-1 9 of U.S. Patent No. 10,130,685 . Although the claims at issue are not identical, they are not patentably distinct from each other because both claim a method of making powders of diketopoperazine loaded with an active agent, e.g., insulin. 1 2 ) Claims 1-10 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-1 9 of U.S. Patent No. 10,583,176 . Although the claims at issue are not identical, they are not patentably distinct from each other because both claim a method of making powders of diketopoperazine loaded with an active agent, e.g., insulin. Conclusion Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000. Any inquiry concerning this communication or earlier communications from the examiner should be directed to FILLIN "Examiner name" \* MERGEFORMAT WALTER E WEBB whose telephone number is FILLIN "Phone number" \* MERGEFORMAT (571)270-3287 and fax number is (571) 270-4287. The examiner can normally be reached from FILLIN "Work schedule?" \* MERGEFORMAT Mon-Fri 7-3:30 . If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sahana K aup can be reached (571) 272- 6897 . The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300. Walter E. Webb /WALTER E WEBB/ Primary Examiner, Art Unit 1612
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Prosecution Timeline

Sep 12, 2023
Application Filed
Mar 19, 2026
Non-Final Rejection — §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
46%
Grant Probability
66%
With Interview (+19.0%)
3y 0m
Median Time to Grant
Low
PTA Risk
Based on 977 resolved cases by this examiner. Grant probability derived from career allow rate.

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