Prosecution Insights
Last updated: April 19, 2026
Application No. 18/326,637

MICROORGANISMS PROGRAMMED TO PRODUCE IMMUNE MODULATORS AND ANTI-CANCER THERAPEUTICS IN TUMOR CELLS

Non-Final OA §102§112
Filed
May 31, 2023
Examiner
BURKHART, MICHAEL D
Art Unit
1638
Tech Center
1600 — Biotechnology & Organic Chemistry
Assignee
Synlogic Operating Company, Inc.
OA Round
1 (Non-Final)
62%
Grant Probability
Moderate
1-2
OA Rounds
3y 3m
To Grant
72%
With Interview

Examiner Intelligence

Grants 62% of resolved cases
62%
Career Allow Rate
507 granted / 811 resolved
+2.5% vs TC avg
Moderate +10% lift
Without
With
+9.9%
Interview Lift
resolved cases with interview
Typical timeline
3y 3m
Avg Prosecution
45 currently pending
Career history
856
Total Applications
across all art units

Statute-Specific Performance

§101
3.8%
-36.2% vs TC avg
§103
27.5%
-12.5% vs TC avg
§102
21.0%
-19.0% vs TC avg
§112
25.2%
-14.8% vs TC avg
Black line = Tech Center average estimate • Based on career data from 811 resolved cases

Office Action

§102 §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 . 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. Claim(s) 1, 2, 40-45, 55, 59-62 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Szalay et al (US 20050031643 A1). Szalay et al teach therapeutic, non-pathogenic microorganisms for administration to tumors (such as E. coli, a facultative anaerobic bacterium) genetically engineered (transformed with a plasmid) to express the DeoD gene cassette, a gene for depleting adenosine according to the instant specification and claims. See, e.g., the abstract, ¶’s [0007], [0013], [0228], [0566]. The promoter may be inducible (¶’s [0165], [0238]). The microorganisms may include the nupG gene from E. coli (¶ [0182]). The microorganisms are taught with pharmaceutically acceptable carriers (¶’s [0018], [0365]) and can be administered intratumorally (¶ [0279). One type of cancer taught is breast cancer (¶ [0565]). Claim Rejections - 35 USC § 112 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. Claim 43 is 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 43 recites bacterium encoding a “nucleoside transporter” but is dependent upon claim 42 which recites an adenosine transporter. Adenosine is one of several common nucleosides. 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. Claim Objections Claim 2 objected to because of the following informalities: the claim recites “Gram positive bacterium” twice in an or conjunction. Appropriate correction is required. Applicant is advised that should claim 42 be found allowable, claim 44 will be objected to under 37 CFR 1.75 as being a substantial duplicate thereof. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m). Claim 44 repeats the adenosine transporter limitation in the same bacterium as claim 42, thus, the claims do not differ in scope. Allowable Subject Matter Claims 9, 54, 56-58, 63 and 64 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. Any inquiry concerning this communication or earlier communications from the examiner should be directed to Michael Burkhart whose telephone number is (571)272-2915. The examiner can normally be reached M-F 8-5. 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, Tracy Vivlemore can be reached at 571 272-2914. 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. /MICHAEL D BURKHART/Primary Examiner, Art Unit 1638
Read full office action

Prosecution Timeline

May 31, 2023
Application Filed
Jan 10, 2026
Non-Final Rejection — §102, §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
62%
Grant Probability
72%
With Interview (+9.9%)
3y 3m
Median Time to Grant
Low
PTA Risk
Based on 811 resolved cases by this examiner. Grant probability derived from career allow rate.

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