Prosecution Insights
Last updated: July 17, 2026
Application No. 18/841,478

COMPOUNDS AND METHODS USEFUL FOR STABILIZING PHENYLALANINE HYDROXYLASE MUTATIONS

Non-Final OA §102
Filed
Aug 26, 2024
Priority
Feb 28, 2022 — provisional 63/314,580 +1 more
Examiner
PIHONAK, SARAH
Art Unit
Tech Center
Assignee
Agios Pharmaceuticals Inc.
OA Round
1 (Non-Final)
61%
Grant Probability
Moderate
1-2
OA Rounds
11m
Est. Remaining
99%
With Interview

Examiner Intelligence

Grants 61% of resolved cases
61%
Career Allowance Rate
912 granted / 1495 resolved
+1.0% vs TC avg
Strong +43% interview lift
Without
With
+43.1%
Interview Lift
resolved cases with interview
Typical timeline
2y 9m
Avg Prosecution
46 currently pending
Career history
1533
Total Applications
across all art units

Statute-Specific Performance

§101
0.7%
-39.3% vs TC avg
§103
43.8%
+3.8% vs TC avg
§102
4.8%
-35.2% vs TC avg
§112
11.0%
-29.0% vs TC avg
Black line = Tech Center average estimate • Based on career data from 1495 resolved cases

Office Action

§102
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 Priority 18841478, filed 08/26/2024, is a National Stage entry of PCT/US2023/013990, International Filing Date: 02/27/2023. PCT/US2023/013990 Claims Priority from Provisional Application 63314580, filed 02/28/2022. Status of Claims Claims 1, 4, 10, 15, 23, 28, 31, 36, 50, 64-69, 72-73, 78, 80-83, 85, 87, 93, 95, 98, and 100 are currently pending. Claims 2-3, 5-9, 11-14, 16-22, 24-27, 29-30, 32-35, 37-49, 51-63, 70-71, 74-77, 79, 84, 86, 88-92, 94, 96-97, 99, and 101-104 have been canceled. Claims 1, 4, 10, 15, 23, 28, 31, 36, 50, 64-69, 72-73, 78, 80-83, 85, 87, 93, 95, 98, and 100 were examined. Claims 1, 4, 15, 23, and 81-82 are rejected. Claims 10, 28, 31, 36, 50, 64-69, 72-73, 78, 80, 83, 85, 87, 93, 95, 98, and 100 are objected to. 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, 4, 15, 23, and 81-82 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Aurora Fine Chemicals, published at various dates in 2020-2021 (CAS records displayed below). Aurora Fine Chemical disclosed the following compounds that are included within formula I: PNG media_image1.png 200 400 media_image1.png Greyscale PNG media_image2.png 200 400 media_image2.png Greyscale PNG media_image3.png 200 400 media_image3.png Greyscale PNG media_image4.png 200 400 media_image4.png Greyscale PNG media_image5.png 200 400 media_image5.png Greyscale . For the above shown compounds, R1 is selected from one of the bicyclic structures recited in instant claim 1; R5=H; R5A=H; R3, R4= each H; m=1; L=-C(O)-; w=0 or 1; x=0 or 1; Ra=methyl or fluoro; and R2=methyl. Claims 81-82 recite the compound as the R-enantiomer, and from the above shown compounds the different enantiomers would have been encompassed by the shown structures. Aurora Fine Chemicals therefore anticipates the claims. Claim Objections Claims 10, 28, 31, 36, 50, 64-69, 72-73, 78, 80, 83, 85, 87, 93, 95, 98, and 100 are 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. Information Disclosure Statements The IDS filed on 4/17/25 have been considered. Correspondence Any inquiry concerning this communication or earlier communications from the examiner should be directed to SARAH PIHONAK whose telephone number is (571)270-7710. The examiner can normally be reached Monday-Friday 9:00-5:30 EST. 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, Kortney Klinkel can be reached at 571-270-5239. 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. SARAH . PIHONAK Primary Examiner Art Unit 1627 /SARAH PIHONAK/Primary Examiner, Art Unit 1627
Read full office action

Prosecution Timeline

Aug 26, 2024
Application Filed
Jul 02, 2026
Non-Final Rejection mailed — §102 (current)

Precedent Cases

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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
61%
Grant Probability
99%
With Interview (+43.1%)
2y 9m (~11m remaining)
Median Time to Grant
Low
PTA Risk
Based on 1495 resolved cases by this examiner. Grant probability derived from career allowance rate.

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