Prosecution Insights
Last updated: August 15, 2026
Application No. 18/563,157

TRANSAMINASE ENZYMES FOR THE TRANSAMINATION OF (1S,5R)-6,8-DIOXABICYCLO[3.2.1]OCTAN-4-ONE

Non-Final OA §112
Filed
Nov 21, 2023
Priority
May 28, 2021 — provisional 63/194,298 +2 more
Examiner
HUTSON, RICHARD G
Art Unit
1652
Tech Center
1600 — Biotechnology & Organic Chemistry
Assignee
Merck Sharp & Dohme LLC
OA Round
1 (Non-Final)
65%
Grant Probability
Favorable
1-2
OA Rounds
9m
Est. Remaining
99%
With Interview

Examiner Intelligence

Grants 65% — above average
65%
Career Allowance Rate
586 granted / 902 resolved
+5.0% vs TC avg
Strong +53% interview lift
Without
With
+52.9%
Interview Lift
resolved cases with interview
Typical timeline
3y 6m
Avg Prosecution
54 currently pending
Career history
955
Total Applications
across all art units

Statute-Specific Performance

§101
3.4%
-36.6% vs TC avg
§103
22.2%
-17.8% vs TC avg
§102
23.2%
-16.8% vs TC avg
§112
39.5%
-0.5% vs TC avg
Black line = Tech Center average estimate • Based on career data from 902 resolved cases

Office Action

§112
DETAILED ACTION 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 . Applicant’s cancellation of claims 6-9, in the paper of 4/8/2025, is acknowledged. Claims 1-27 are still at issue and are present for examination. Election/Restrictions Applicant's election without traverse of the invention of Group V, claims 1, 14-16, 23-27, drawn to transaminase of SEQ ID NO:6, in the paper of 5/22/2026, is acknowledged. Claims 2-13, 17-22 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species Information Disclosure Statement The listing of references in the specification is not a proper information disclosure statement. 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609 A(1) states, "the list may not be incorporated into the specification but must be submitted in a separate paper." Applicants filing of information disclosure statements on 4/24/2024 and 3/25/2025 are acknowledged and have been considered. Claim Objections Claim 1 is objected to because of the following informalities: Claim 1 comprises non-elected subject matter that has not yet been considered. Appropriate correction and/or comment is required. Claim Rejections - 35 USC § 112 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. The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph: The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention. Claims 23-27 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 23 (claims 24-27 dependent on) recites the limitation "the transaminase enzymes" of Claim 1. There is insufficient antecedent basis for this limitation in the claim. Further it rases the question if it is applicants intent that multiple transaminases as listed in claim 1 are operably linked to one or more control sequences. Appropriate correction and/or comment is required. The following is a quotation of 35 U.S.C. 112(d): (d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers. The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph: Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers. Claims 14-16 rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claim 14 (claims 15 and 16 dependent on) is drawn to “the transaminase enzyme of claim 1, comprising an amino acid sequence having at least a 90% sequence identity to SEQ ID NO: 6. Claim 1 is drawn to a transaminase enzyme selected from SEQ ID NO: 2, SEQ ID NO: 3, SEQ ID NO: 4, SEQ ID NO: 5, SEQ ID NO: 6, SEQ ID NO: 7, or SEQ ID NO:8. As each transaminase enzyme sequence listed in claim 1 has greater than 90% sequence identity to SEQ ID NO:6, claim 14 does not further limit claim 1 from which it depends. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements. Closest Prior Art Uniprot Accession No. F7J696, June 17 2020 discloses a transaminase protein isolated from OS Arthrobacter sp. KNK168 which has 88.5 % sequence homology to instant SEQ ID NO:6. WO 2013/036861 (US Patent No: 9,109,209) discloses a transaminase protein isolated from Arthrobacter sp. KNK168 which has 96.1 % sequence homology to instant SEQ ID NO:6. WO 2013/036861 (US Patent No: 9,109,209) discloses a transaminase protein which has 99.7 % sequence homology to instant SEQ ID NO:2, having only a single mismatch at position A5 of SEQ ID NO:2. Remarks No claim is allowed. Any inquiry concerning this communication or earlier communications from the examiner should be directed to RICHARD G HUTSON whose telephone number is (571)272-0930. The examiner can normally be reached 6-3 EST Mon-Fri. 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, Robert Mondesi can be reached at (408) 918-7584. 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. rgh 7/17/2026 /RICHARD G HUTSON/Primary Examiner, Art Unit 1652
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Prosecution Timeline

Nov 21, 2023
Application Filed
Jul 21, 2026
Non-Final Rejection mailed — §112 (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
65%
Grant Probability
99%
With Interview (+52.9%)
3y 6m (~9m remaining)
Median Time to Grant
Low
PTA Risk
Based on 902 resolved cases by this examiner. Grant probability derived from career allowance rate.

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