Prosecution Insights
Last updated: October 25, 2026
Application No. 18/812,253

COMPOSITIONS COMPRISING STREPTOCOCCUS PNEUMONIAE POLYSACCHARIDE-PROTEIN CONJUGATES AND METHODS OF USE THEREOF

Non-Final OA §112
Filed
Aug 22, 2024
Priority
Dec 06, 2017 — provisional 62/595,388 +3 more
Examiner
GANGLE, BRIAN J
Art Unit
1645
Tech Center
1600 — Biotechnology & Organic Chemistry
Assignee
Merck Sharp & Dohme LLC
OA Round
1 (Non-Final)
77%
Grant Probability
Favorable
1-2
OA Rounds
5m
Est. Remaining
91%
With Interview

Examiner Intelligence

Grants 77% — above average
77%
Career Allowance Rate
738 granted / 961 resolved
+16.8% vs TC avg
Moderate +15% lift
Without
With
+14.6%
Interview Lift
resolved cases with interview
Typical timeline
2y 7m
Avg Prosecution
45 currently pending
Career history
1018
Total Applications
across all art units

Statute-Specific Performance

§101
6.5%
-33.5% vs TC avg
§103
16.3%
-23.7% vs TC avg
§102
21.7%
-18.3% vs TC avg
§112
38.1%
-1.9% vs TC avg
Black line = Tech Center average estimate • Based on career data from 961 resolved cases

Office Action

§112
CTNF 18/812,253 CTNF 81384 DETAILED ACTION Notice of Pre-AIA or AIA Status 07-03-aia AIA 15-10-aia The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA. Claims 1-10 are pending and are currently under examination. Information Disclosure Statement The information disclosure statements filed on 11/20/2024 and 2/11/2026 have been considered. Signed copies are enclosed. Claim Rejections - 35 USC § 112 07-30-02 AIA The following is a quotation of 35 U.S.C. 112(b): (B) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention. The following is a quotation of 35 U.S.C. 112 (pre-AIA), second paragraph: The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention. 07-34-01 AIA Claim s 1-10 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor, or for pre-AIA the applicant regards as the invention. Claims 1-10 are indefinite because the required ratio of polysaccharide to carrier protein is not possible with the range of molecular weights required by the claims. Further, it is not clear what units are to be used to determine the ratio. If the ratio is based on number of molecules, the molecular weights are not possible. If the ratio is based on mass, only a portion of the ranges is possible. For example, with polysaccharide at a molecular weight of 500 kDa, the conjugate could only have a molecular weight between 1000 and 1120 kDa while maintaining the required ratio. If the molecular weight of the conjugate is 1000 kDa, the polysaccharide could only have a molecular weight between 445 and 500 kDa. 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, Anne Gussow can be reached at 571-272-6047. 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 Application/Control Number: 18/812,253 Page 2 Art Unit: 1645 Application/Control Number: 18/812,253 Page 3 Art Unit: 1645
Read full office action

Prosecution Timeline

Aug 22, 2024
Application Filed
May 07, 2026
Non-Final Rejection mailed — §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
77%
Grant Probability
91%
With Interview (+14.6%)
2y 7m (~5m remaining)
Median Time to Grant
Low
PTA Risk
Based on 961 resolved cases by this examiner. Grant probability derived from career allowance rate.

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