Prosecution Insights
Last updated: April 19, 2026
Application No. 18/111,321

Highly Potent Acid Alpha-Glucosidase With Enhanced Carbohydrates

Non-Final OA §112§Other
Filed
Feb 17, 2023
Examiner
MEAH, MOHAMMAD Y
Art Unit
1652
Tech Center
1600 — Biotechnology & Organic Chemistry
Assignee
Amicus Therapeutics, Inc.
OA Round
2 (Non-Final)
71%
Grant Probability
Favorable
2-3
OA Rounds
3y 1m
To Grant
99%
With Interview

Examiner Intelligence

Grants 71% — above average
71%
Career Allow Rate
692 granted / 977 resolved
+10.8% vs TC avg
Strong +43% interview lift
Without
With
+42.9%
Interview Lift
resolved cases with interview
Typical timeline
3y 1m
Avg Prosecution
7 currently pending
Career history
984
Total Applications
across all art units

Statute-Specific Performance

§101
1.8%
-38.2% vs TC avg
§103
35.1%
-4.9% vs TC avg
§102
20.6%
-19.4% vs TC avg
§112
22.7%
-17.3% vs TC avg
Black line = Tech Center average estimate • Based on career data from 977 resolved cases

Office Action

§112 §Other
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 Claims 1-9, 13--33 are pending A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed on 2/9/26 in this application after the allowance. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicants’ submission filed on 2/9/26 has been entered. Information Disclosure Statement The information disclosure statement (IDS) submitted on 2/9/26 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the examiner has considered the IDS statement. Rejection Claim Rejections 35 U.S.C 112(b) rejection 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. Claim 33 is 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 applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention. Claim 33 is rejected because it recites the limitation “ means”. It is unclear what include in the word means and render the claims indefinite because the metes and bounds of the claim is indefinite. Claim 33 is rejected because it recites the limitation “ said means”. It is unclear what include in word said means and render the claims indefinite because the metes and bounds of the claim is indefinite. Claim 33 is rejected because it recites the limitation “at least about 3%”. The limitations “at least” and “about” render the claims indefinite because the metes and bounds of the claim is indefinite. Claim Rejections, 35 U.S.C 112 1st Paragraph The following is a quotation of the first paragraph of 35 U.S.C. 112: The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same and shall set forth the best mode contemplated by the inventor of carrying out his invention. Claim 33 is rejected under 35 U.S.C. 112, first paragraph, as containing subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor(s), at the time the application was filed, had possession of the claimed invention. Claims 115-137 are rejected under 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph - written description requirement, first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor(s), at the time the application was filed, had possession of the claimed invention. The amendments filed 2/9/26 is objected under 35 U.S.C. 132 because it introduces new matter into the disclosure (claim). 35 U.S.C. 132 states that no amendment shall introduce new matter into the disclosure of the invention. The added material which is not supported by the original disclosure is as follows: Claim 33 recites the phrase ‘a means for increasing the efficiency” and also “said means, wherein said means”; specification and original claims do not recite a means for increasing the efficiency” and also “said means, wherein said means---". . The phrase added into the claim 33 was not part of the original specification and claims and the invention as claimed was not envisioned or foreseen as originally filed. Applicant is required to cancel the new matter in the reply to this Office Action. Conclusion Claims 1-9, 13-32 are allowed, Claim 33 is rejected. Any inquiry concerning this communication or earlier communications from the examiner should be directed to Mohammad Meah whose telephone number is 571-272- 1261. The examiner can normally be reached on 8:30-5PM. If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Robert Mondesi can be reached on 4089187584. 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 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. /MOHAMMAD Y MEAH/Examiner, Art Unit 1652
Read full office action

Prosecution Timeline

Feb 17, 2023
Application Filed
Feb 17, 2023
Response after Non-Final Action
Dec 13, 2023
Examiner Interview Summary
Dec 13, 2023
Examiner Interview (Telephonic)
Jun 03, 2024
Non-Final Rejection — §112, §Other
Nov 14, 2024
Response Filed
Dec 23, 2024
Examiner Interview (Telephonic)
Apr 23, 2025
Request for Continued Examination
Apr 25, 2025
Response after Non-Final Action
Oct 07, 2025
Request for Continued Examination
Oct 08, 2025
Response after Non-Final Action
Feb 09, 2026
Request for Continued Examination
Feb 11, 2026
Response after Non-Final Action
Feb 17, 2026
Non-Final Rejection — §112, §Other (current)

Precedent Cases

Applications granted by this same examiner with similar technology

Patent 12601737
CONJUGATE FOR IMMUNODETECTION BASED ON LATERAL FLOW ASSAY, AND IMMUNODETECTION METHOD USING SAME
2y 5m to grant Granted Apr 14, 2026
Patent 12570997
FACTOR H VECTORS AND USES THEREOF
2y 5m to grant Granted Mar 10, 2026
Patent 12565523
STRUCTURE-GUIDED ENGINEERING OF PEPTIDE-BASED NLRP3 INFLAMMASOME INHIBITORS FOR MYELODYSPLASTIC SYNDROMES (MDS)
2y 5m to grant Granted Mar 03, 2026
Patent 12565646
ENHANCED PLATFORMS FOR UNNATURAL AMINO ACID INCORPORATION IN MAMMALIAN CELLS
2y 5m to grant Granted Mar 03, 2026
Patent 12559759
FUSION POLYPEPTIDES
2y 5m to grant Granted Feb 24, 2026
Study what changed to get past this examiner. Based on 5 most recent grants.

AI Strategy Recommendation

Get an AI-powered prosecution strategy using examiner precedents, rejection analysis, and claim mapping.
Powered by AI — typically takes 5-10 seconds

Prosecution Projections

2-3
Expected OA Rounds
71%
Grant Probability
99%
With Interview (+42.9%)
3y 1m
Median Time to Grant
Moderate
PTA Risk
Based on 977 resolved cases by this examiner. Grant probability derived from career allow 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