Prosecution Insights
Last updated: October 02, 2026
Application No. 18/111,321

Highly Potent Acid Alpha-Glucosidase With Enhanced Carbohydrates

Non-Final OA §112
Filed
Feb 17, 2023
Priority
Sep 30, 2014 — provisional 62/057,847 +9 more
Examiner
MEAH, MOHAMMAD Y
Art Unit
1652
Tech Center
1600 — Biotechnology & Organic Chemistry
Assignee
Amicus Therapeutics Inc.
OA Round
3 (Non-Final)
71%
Grant Probability
Favorable
3-4
OA Rounds
0m
Est. Remaining
99%
With Interview

Examiner Intelligence

Grants 71% — above average
71%
Career Allowance Rate
694 granted / 980 resolved
+10.8% vs TC avg
Strong +43% interview lift
Without
With
+42.7%
Interview Lift
resolved cases with interview
Typical timeline
3y 0m
Avg Prosecution
55 currently pending
Career history
1002
Total Applications
across all art units

Statute-Specific Performance

§101
4.2%
-35.8% vs TC avg
§103
26.2%
-13.8% vs TC avg
§102
17.3%
-22.7% vs TC avg
§112
39.5%
-0.5% vs TC avg
Black line = Tech Center average estimate • Based on career data from 980 resolved cases

Office Action

§112
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 33-49 submitted on 05/19/2026 are pending for examination. In reply to the non-final action of 02/09/2026, the applicants’ argument is acknowledged. Rejections and/or objections not reiterated from previous office actions 02/09/2026 are hereby withdrawn. Claim Objection Objection of claims 34-35 and 42-43 for the recitation of “per mol rhGAA”. Claim 33 was amended to insert “of” but claims 34-35 and 42-43 were not amended. Correction Required. Objection of claim 36 for missing a conjunction in line 3, between “glycan” and “at least”. Correction Required. Objection of claims 36-37 for the recitation of the acronym “CIMPR”. Correction Required. 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 34-35 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 applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention. Claim 34 is rejected because for lack of antecedence for reciting “the average content of N- glycans carrying M6P”. Claim 34 depends on claim 33. Claim 33 does not recite” average content of N- glycans carrying M6P”. Therefore Claim 34 lack of antecedence for reciting the average content of N- glycans carrying M6P. Claim 35 is rejected because for lack of antecedence for reciting “the average content of N- glycans carrying M6P”. Claim 34 depends on claim 33. Claim 33 does not recite” average content of N- glycans carrying M6P”. Therefore Claim 34 lack of antecedence for reciting the average content of N- glycans carrying M6P. Conclusion Claims 34-35 are rejected. Claims 34-37 and 42-43 are objected. Claims 33, 38-41 and 44-49 are allowed,. 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

Show 8 earlier events
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 19, 2026
Non-Final Rejection mailed — §112
May 19, 2026
Response Filed
Aug 07, 2026
Non-Final Rejection mailed — §112 (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

3-4
Expected OA Rounds
71%
Grant Probability
99%
With Interview (+42.7%)
3y 0m (~0m remaining)
Median Time to Grant
High
PTA Risk
Based on 980 resolved cases by this examiner. Grant probability derived from career allowance rate.

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