Prosecution Insights
Last updated: October 04, 2026
Application No. 18/322,723

SURFACE-ENGINEERED EXTRACELLULAR VESICLES AND THERAPEUTIC USES THEREOF

Final Rejection §102§112§Other
Filed
May 24, 2023
Priority
May 24, 2022 — provisional 63/345,040
Examiner
WILSON, MICHAEL C
Art Unit
1638
Tech Center
1600 — Biotechnology & Organic Chemistry
Assignee
Shiftbio Inc.
OA Round
2 (Final)
42%
Grant Probability
Moderate
3-4
OA Rounds
4m
Est. Remaining
59%
With Interview

Examiner Intelligence

Grants 42% of resolved cases
42%
Career Allowance Rate
390 granted / 939 resolved
-18.5% vs TC avg
Strong +18% interview lift
Without
With
+17.9%
Interview Lift
resolved cases with interview
Typical timeline
3y 8m
Avg Prosecution
64 currently pending
Career history
1010
Total Applications
across all art units

Statute-Specific Performance

§101
4.4%
-35.6% vs TC avg
§103
29.6%
-10.4% vs TC avg
§102
15.7%
-24.3% vs TC avg
§112
39.2%
-0.8% vs TC avg
Black line = Tech Center average estimate • Based on career data from 939 resolved cases

Office Action

§102 §112 §Other
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 arguments filed 6-25-26 have been fully considered but they are not persuasive. The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action. Claims 1-32 remain pending. Election/Restrictions Applicants elected Group I, claims 1-19, with traverse in the reply filed 12-11-25. Applicants elected SEQ ID NO: 1-8, 13, 14 for the species election. Claims 12-15 remain withdrawn because they do not relate to the elected invention because they are not limited to the elected species of SEQ ID NO: 1-8, 13, 14. Claims 20-32 remain withdrawn because they are not part of elected Group I. Claims 1-11, 16-19 remain under consideration. Claim Rejections - 35 USC § 112 The following is a quotation of the first paragraph of 35 U.S.C. 112(a): (a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention. The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112: The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention. Claims 1-11, 16-19 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. Claim 1 as newly amended is drawn to a nucleic acid sequence having the structure of G-a-S-b-X1-c-X2 that does not comprise the amino acid sequence of SEQ ID NO: 1. Applicant point to support including SEQ ID NO: 1-100 and say “SEQ ID NO: 1 is merely one expressly disclosed species within the originally described genus”. However, the specification did not contemplate excluding SEQ ID NO: 1 from the genus. Therefore, the new subgenus claimed lacking SEQ ID NO: 1 lacks written description because it was not contemplated in the original disclosure. Claim Rejections - 35 USC § 102 The rejection of claims 1-11, 16, 17 under 35 U.S.C. 102a1 as being anticipated by Zimin (Biol. Direct, 2014, Vol. 9, No. 20, pg 1-15) has been withdrawn because it is reliant upon SEQ ID NO: 8 of Zimin being 100% identical to applicants’ SEQ ID NO: 1; however, SEQ ID NO: 1 has been excluded from claim 1 as newly amended. PNG media_image1.png 180 1292 media_image1.png Greyscale Claims 1-11, 16, 17 are rejected under 35 U.S.C. 102a1 as being anticipated by Upasna (Animal Genetics, 2011, JO457460). Upasna taught a nucleic acid sequence that is JO457460 which is 100% identical to SEQ ID NO: 2. PNG media_image2.png 180 1280 media_image2.png Greyscale JO457460 meets all the limitations of claims 2-11. Claim 16 has been included because JO457460 is the “amino acid of a target protein”. Claim 17 has been included because applicants teach JO457460 can be used as a “therapeutic protein”. Claim 18 has been included because genomic DNA was cloned using standard with BACs (Materials and Methods) which inherently MUST use vectors and host cells comprising the vectors. Conclusion No claim is allowed. Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a). A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action. Inquiry concerning this communication or earlier communications from the examiner should be directed to Michael C. Wilson who can normally be reached at the office on Monday through Friday from 9:30 am to 6:00 pm at 571-272-0738. Patent applicants with problems or questions regarding electronic images that can be viewed in the Patent Application Information Retrieval system (PAIR) can now contact the USPTO’s Patent Electronic Business Center (Patent EBC) for assistance. Representatives are available to answer your questions daily from 6 am to midnight (EST). The toll free number is (866) 217-9197. When calling please have your application serial or patent number, the type of document you are having an image problem with, the number of pages and the specific nature of the problem. The Patent Electronic Business Center will notify applicants of the resolution of the problem within 5-7 business days. Applicants can also check PAIR to confirm that the problem has been corrected. The USPTO’s Patent Electronic Business Center is a complete service center supporting all patent business on the Internet. The USPTO’s PAIR system provides Internet-based access to patent application status and history information. It also enables applicants to view the scanned images of their own application file folder(s) as well as general patent information available to the public. For all other customer support, please call the USPTO Call Center (UCC) at 800-786-9199. If attempts to reach the examiner are unsuccessful, the examiner's supervisor, Tracy Vivlemore, can be reached on 571-272-2914. The official fax number for this Group is (571) 273-8300. Michael C. Wilson /MICHAEL C WILSON/ Primary Examiner, Art Unit 1638
Read full office action

Prosecution Timeline

May 24, 2023
Application Filed
Mar 26, 2026
Non-Final Rejection mailed — §102, §112, §Other
Jun 25, 2026
Response Filed
Sep 18, 2026
Final Rejection mailed — §102, §112, §Other (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

3-4
Expected OA Rounds
42%
Grant Probability
59%
With Interview (+17.9%)
3y 8m (~4m remaining)
Median Time to Grant
Moderate
PTA Risk
Based on 939 resolved cases by this examiner. Grant probability derived from career allowance rate.

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