Prosecution Insights
Last updated: May 29, 2026
Application No. 18/516,772

BIO-MICROBUR THERAPEUTIC DELIVERY PLATFORM

Non-Final OA §103
Filed
Nov 21, 2023
Priority
May 21, 2021 — provisional 63/191,586 +3 more
Examiner
GEMBEH, SHIRLEY V
Art Unit
1615
Tech Center
1600 — Biotechnology & Organic Chemistry
Assignee
The Trustees of Columbia University in the City of New York
OA Round
1 (Non-Final)
63%
Grant Probability
Moderate
1-2
OA Rounds
1m
Est. Remaining
97%
With Interview

Examiner Intelligence

Grants 63% of resolved cases
63%
Career Allowance Rate
1019 granted / 1614 resolved
+3.1% vs TC avg
Strong +34% interview lift
Without
With
+34.0%
Interview Lift
resolved cases with interview
Typical timeline
2y 7m
Avg Prosecution
31 currently pending
Career history
1653
Total Applications
across all art units

Statute-Specific Performance

§101
0.4%
-39.6% vs TC avg
§103
53.9%
+13.9% vs TC avg
§102
4.6%
-35.4% vs TC avg
§112
2.2%
-37.8% vs TC avg
Black line = Tech Center average estimate • Based on career data from 1614 resolved cases

Office Action

§103
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 1-10 and 19-20) in the reply filed on 2/25/26 is acknowledged. However it is not clear as Applicant also elected with traverse that the elected group would directly cover the elected Group. As stated in the restriction requirement a possible rejoinder if the group is found allowable. The restriction is made FINAL. Information Disclosure Statement Receipt is acknowledged of the Information Disclosure Statement filed October 06, 2025. The Examiner has considered the references cited therein to the extent that each is a proper citation. Please see the attached USPTO Form 1449. Claim Objections Claims 19-20 are objected to because of the following informalities: the abbreviation SSRI and MB-MSN-SSRI should be spelled out when first used. Appropriate correction is required. Claim Rejections - 35 USC § 103 The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action: A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made. The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows: 1. Determining the scope and contents of the prior art. 2. Ascertaining the differences between the prior art and the claims at issue. 3. Resolving the level of ordinary skill in the pertinent art. 4. Considering objective evidence present in the application indicating obviousness or nonobviousness. This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention. Claim(s) 1-10 and 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Yang et al. (CN 106495232 Applicants IDS submission) and (as evidenced by Kurakula et al. J.Drug Deliv. Sci Technol 2020 2(60) ) in view of Zhang et al. (Applied Bio Materials 2020 3 4514-4521). With regards to instant claim 1, Yang teaches a 3D multifunctional hollow sea urchin-type nanocomposite drug carrying system having a spherical hollow Fe3O4 center comprising coated metal oxide ZnO nanorods targeted for drug delivery (see 0005-0007), having a particle size from 1-1.5 µm (see 0008, upon conversion 1 µm is equal to 1000 nanometers, thus falls within the recited range as recited by instant claim 8). Yang further teaches that the hollow sphere is coated and a plurality of nanoneedles (as recited by instant claim 2) and have advantage in treatment and drug delivery and therefore reasonable that the 3D multifunctional hollow sea urchin-type nanocomposite drug carrying system may have attaches a functional agent (as required by instant claims 3-5) therefore one of ordinary skill in the art would assume the nanoneedles are loaded with a therapeutic agent and wherein it comprises a biodegradable material a polyvinylpyrrolidone (as required by instant claim 8-9). However Yang fails to teach specifically that the nanoneedles are coated with the therapeutic agent and that the nanoneedles comprise a biodegradable material. Even though the reference did not explicitly teach that the nanoneedles, nonetheless teaches the inclusion of a biodegradable material (see as evidenced by Kurakula et al.). Zhang teaches that sea uchin is a multidrug carrier (see entire article. However did not specifically teach the therapeutic agent is an SSRI in claims 19-20. Nonetheless, one of ordinary skill in the art would have been motivated to use any drug as the reference recognized that urchin-type nanocomposite are known for its drug carrying system and therefore a reasonable expectation of success in using any drug to accomplish the goal of using an urchin-type nanocomposite drug as a carrying system. Although neither reference teach the drug been SSRI, nonetheless it would have been obvious to one of ordinary skill in the art would have been motivated to use any drug to include a serotonin type drug because, MPEP 2143 states "when there is motivation to solve a problem and there are a finite number of identified, predictable solutions, a person of ordinary skill has good reason to pursue the known options within his or her technical grasp. If this leads to anticipated success, it is likely the product not of innovation but of ordinary skill and common sense." Therefore that the skilled artisan would have had reason to try these methods with the reasonable expectation that at least one would be successful. It would have been obvious to one of ordinary skill in the art to have been motivated to combine the cited prior art for their teachings to result in the instant claimed invention. Claim 20 is 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 SHIRLEY V GEMBEH whose telephone number is (571)272-8504. The examiner can normally be reached M-F 9am-6pm. 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 A. Wax can be reached at 571-272-0623. 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. /SHIRLEY V GEMBEH/Primary Examiner, Art Unit 1615 4/6/26
Read full office action

Prosecution Timeline

Nov 21, 2023
Application Filed
Apr 09, 2026
Non-Final Rejection mailed — §103 (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
63%
Grant Probability
97%
With Interview (+34.0%)
2y 7m (~1m remaining)
Median Time to Grant
Low
PTA Risk
Based on 1614 resolved cases by this examiner. Grant probability derived from career allowance rate.

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