Prosecution Insights
Last updated: April 19, 2026
Application No. 18/023,301

SIGNAL PEPTIDE FOR REDUCING END HETEROGENEITY OF HETEROLOGOUS POLYPEPTIDE

Non-Final OA §102
Filed
Feb 24, 2023
Examiner
GANGLE, BRIAN J
Art Unit
1645
Tech Center
1600 — Biotechnology & Organic Chemistry
Assignee
Shanghai Hengrui Pharmaceutical Co. Ltd.
OA Round
1 (Non-Final)
76%
Grant Probability
Favorable
1-2
OA Rounds
2y 8m
To Grant
92%
With Interview

Examiner Intelligence

Grants 76% — above average
76%
Career Allow Rate
718 granted / 940 resolved
+16.4% vs TC avg
Strong +15% interview lift
Without
With
+15.4%
Interview Lift
resolved cases with interview
Typical timeline
2y 8m
Avg Prosecution
28 currently pending
Career history
968
Total Applications
across all art units

Statute-Specific Performance

§101
4.5%
-35.5% vs TC avg
§103
15.0%
-25.0% vs TC avg
§102
23.0%
-17.0% vs TC avg
§112
36.6%
-3.4% vs TC avg
Black line = Tech Center average estimate • Based on career data from 940 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 II in the reply filed on 12/5/2025 is acknowledged. Claims 1-16 are pending. Claims 1-5 and 10-16 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.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 6-9 are currently under examination. Information Disclosure Statement The information disclosure statement filed on 2/24/2023 has been considered. A signed copy is enclosed. Specification The use of the trademark TWEEN has been noted in this application on page 40. It should be capitalized wherever it appears and be accompanied by the generic terminology. Although the use of trademarks is permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as trademarks. It is noted that the cited occurrence of improper use is only exemplary and applicant should review the specification to correct any other use of trademarks. Claim Objections Claims 8-9 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. Claim Rejections - 35 USC § 102 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. Claims 6-7 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Brown et al (US Patent Application Publication 2011/0091480). The instant claims are drawn to polypeptides comprising a signal peptide comprising an amino acid sequence of SEQ ID NO:55 or 56. Brown et al disclose antibody light chains comprising a signal peptide with the sequence of SEQ ID NO:27, which matches the instantly claimed SEQ ID NO:56 at 100% (see paragraph 0180). Conclusion No claim is allowed. Any inquiry concerning this communication or earlier communications from the examiner should be directed to Brian J Gangle whose telephone number is (571)272-1181. The examiner can normally be reached M-F, 9-6:30. 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, Daniel Kolker can be reached at 571-272-3181. 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. /BRIAN GANGLE/Primary Examiner, Art Unit 1645
Read full office action

Prosecution Timeline

Feb 24, 2023
Application Filed
Feb 06, 2026
Non-Final Rejection — §102 (current)

Precedent Cases

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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
76%
Grant Probability
92%
With Interview (+15.4%)
2y 8m
Median Time to Grant
Low
PTA Risk
Based on 940 resolved cases by this examiner. Grant probability derived from career allow rate.

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