Prosecution Insights
Last updated: April 19, 2026
Application No. 18/251,314

ANTI-RESPIRATORY SYNCYTIAL VIRUS (RSV) ANTIBODY CELL-BASED POTENCY ASSAY

Non-Final OA §112
Filed
May 01, 2023
Examiner
BURKHART, MICHAEL D
Art Unit
1638
Tech Center
1600 — Biotechnology & Organic Chemistry
Assignee
Merck Sharp & Dohme LLC
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

§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 § 112 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. Claims 31-33 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 applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention. Claims 31-33 depend upon canceled claim 27, thus, the metes and bounds of the claimed subject matter cannot be determined. Allowable Subject Matter Claims 1, 5-8, 12-16, 18-20, 22-26 are allowed. The prior art does not teach or fairly suggest flanking a reporter gene with SEQ ID NO:16 (RSV P gene start) and SEQ ID NO:17 (RSV NS2 gene end) and placement between the P and M genes in a viral vector. The closest prior art is Rameix-Welti et al (2014, of record) which teaches such a vector but with a P gene start sequence and an N gene end sequence. Further, SEQ ID NO: 16 differs from a canonical RSV P gene start (Collins et al, 2016, Fig. 3) by one residue: 1 ggggcaaataaatca 15 SIN:16 ccccguuuauuuacu complement RNA of SEQ ID NO: 16 ccccguuuauuuagu rsv P start of Collins et al. Further, previous fluorescence-based RSV reporter virus antibody neutralization assays teach a different placement of the reporter gene in the “first position” next to the NS1 gene, as represented by Fuentes et al (Vaccine, 2013) and Remmerden et al (2012), or between the RSV G and F genes (Remmerden et al). 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
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Prosecution Timeline

May 01, 2023
Application Filed
Jan 09, 2026
Non-Final Rejection — §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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