Prosecution Insights
Last updated: October 04, 2026
Application No. 18/688,938

Therapeutic Engineered Microbial Cell Systems and Methods for Treating Conditions in Which Oxalate is Detrimental

Non-Final OA §102
Filed
Mar 04, 2024
Priority
Sep 09, 2021 — provisional 63/261,034 +1 more
Examiner
STAVROU, CONSTANTINA E
Art Unit
1632
Tech Center
1600 — Biotechnology & Organic Chemistry
Assignee
Unlocked Labs Inc.
OA Round
1 (Non-Final)
44%
Grant Probability
Moderate
1-2
OA Rounds
1y 4m
Est. Remaining
81%
With Interview

Examiner Intelligence

Grants 44% of resolved cases
44%
Career Allowance Rate
38 granted / 87 resolved
-16.3% vs TC avg
Strong +37% interview lift
Without
With
+36.9%
Interview Lift
resolved cases with interview
Typical timeline
3y 11m
Avg Prosecution
46 currently pending
Career history
167
Total Applications
across all art units

Statute-Specific Performance

§101
3.0%
-37.0% vs TC avg
§103
46.4%
+6.4% vs TC avg
§102
19.6%
-20.4% vs TC avg
§112
28.5%
-11.5% vs TC avg
Black line = Tech Center average estimate • Based on career data from 87 resolved cases

Office Action

§102
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 . Election/Restrictions Applicant’s election without traverse of Group I, claims 1-11, in the reply filed on 07/10/2026 is acknowledged. Claims 12-18 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected Groups, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 07/10/2026. Status of the Claims Claims 1-18 are currently pending. Claims 8-12, 16, and 17 are amended. Claims 12-18 have been withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected Invention, there being no allowable generic or linking claim. Claims 1-11 have been considered on the merits. Claim Objections Claim 4 is objected to because of the following informalities: the reaction in claim 4 should contain the term “yields” since the typical chemical reaction arrow is not permissible in the claims. The reaction in line 3 of claim 4 should read as follows: “oxalate + H+ yields formate + CO2” . Appropriate correction is required. Claim 6 is objected to because of the following informalities: the phrase “at least 95% identity with the full length of any one of SEQ ID NOs: 1-4” should be amended to “at least 95% identity with the full length sequence of any one of SEQ ID NOs: 1-4” for clarity. Appropriate correction is required. Claim 7 is objected to because of the following informalities: the phrase “a chimera, a and/or an overexpression…” should be amended to “a chimera, and/or an overexpression”. Appropriate correction is required. Claim Rejections - 35 USC § 102 In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status. 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. (a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention. Claims 1-11 are rejected under 35 U.S.C. 102(a)(1)/102(a)(2) as being anticipated by Russ et al (WO 2020/123483 A1). With regards to claim 1, Russ teaches an engineered microbial cell ([0006]) comprising an exogenous nucleic acid encoding at least one oxalate catabolism enzyme ([0009]/[0094]). Regarding claim 2, Russ teaches wherein the engineered microbial cell is a bacterial cell ([0006]). Regarding claim 3, Russ teaches wherein the encoded oxalate catabolism enzyme is constitutively expressed in the engineered microbial cell ([0094]). Regarding claim 4, Russ teaches wherein the at least one oxalate catabolism enzyme is an oxalate decarboxylase that directly catalyzes the reaction of oxalate + H+ yields formate + CO2 ([0009]/ Figure 1). Regarding claim 5, Russ teaches wherein the at least one oxalate catabolism enzyme is a bacterial oxalate decarboxylase ([0009]/[0079] SEQ ID NO: 40 of Russ has 100% Sequence identity with SEQ ID NO: 1 of instant application). Regarding claim 6, Russ teaches wherein the at least one oxalate catabolism enzyme comprises at least 95% identity with the full length of any one of SEQ ID NOs: 1-4 ([0009]/[0079] SEQ ID NO: 40 of Russ has 100% Sequence identity with SEQ ID NO: 1 of instant application). Regarding claim 7, Russ teaches wherein the oxalate decarboxylase is a functional fragment or variant thereof which meets the limitations of a mutant oxalate decarboxylase, a chimera, and/or an overexpression variant of the oxalate decarboxylase ([0009]). Regarding claim 8, Russ teaches wherein the engineered microbial cell is present in a composition comprising an enteric coating and/or preservative ([0023]/[0106]). Regarding claim 9, Russ teaches wherein the composition is a pharmaceutical composition ([0023]). Regarding claim 10, Russ teaches wherein the pharmaceutical composition comprises a pharmaceutically acceptable carrier ([0023]). Regarding claim 11, Russ teaches wherein the engineered microbial cell is located within the enteric coating ([0023]). Therefore, Russ anticipates the claims. Conclusion No claims are allowed. Examiner Contact Information Any inquiry concerning this communication or earlier communications from the examiner should be directed to CONSTANTINA E STAVROU whose telephone number is (571)272-9899. The examiner can normally be reached M-F 8:00-5:00. 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, Peter Paras can be reached at 571-272-4517. 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. CONSTANTINA E. STAVROU Examiner Art Unit 1632 /TITILAYO MOLOYE/Primary Examiner, Art Unit 1632
Read full office action

Prosecution Timeline

Mar 04, 2024
Application Filed
Sep 22, 2026
Non-Final Rejection mailed — §102 (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
44%
Grant Probability
81%
With Interview (+36.9%)
3y 11m (~1y 4m remaining)
Median Time to Grant
Low
PTA Risk
Based on 87 resolved cases by this examiner. Grant probability derived from career allowance rate.

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