Prosecution Insights
Last updated: October 27, 2026
Application No. 16/131,580

DETECTION OF RECOMBINASE POLYMERASE AMPLIFICATION USING DUAL-HAPTEN PROBE

Final Rejection §112
Filed
Sep 14, 2018
Priority
Sep 14, 2017 — provisional 62/558,705
Examiner
SWITZER, JULIET CAROLINE
Art Unit
1682
Tech Center
1600 — Biotechnology & Organic Chemistry
Assignee
Abbott Diagnostics Scarborough Inc.
OA Round
7 (Final)
42%
Grant Probability
Moderate
8-9
OA Rounds
0m
Est. Remaining
96%
With Interview

Examiner Intelligence

Grants 42% of resolved cases
42%
Career Allowance Rate
219 granted / 516 resolved
-17.6% vs TC avg
Strong +54% interview lift
Without
With
+54.0%
Interview Lift
resolved cases with interview
Typical timeline
3y 8m
Avg Prosecution
44 currently pending
Career history
573
Total Applications
across all art units

Statute-Specific Performance

§101
20.3%
-19.7% vs TC avg
§103
22.4%
-17.6% vs TC avg
§102
15.1%
-24.9% vs TC avg
§112
32.0%
-8.0% vs TC avg
Black line = Tech Center average estimate • Based on career data from 516 resolved cases

Office Action

§112
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 . The 112b rejection over “a target deoxyribonucleic acid” is moot because this language was cancelled out of claim 1. The 112b rejection over the “probe” length is withdrawn because this is an issue of claim breadth and not indefiniteness. A probe comprising a single-stranded DNA is a well known structure in the prior art. There is no question as to metes and bounds. The rejection for lack of enablement is withdrawn because there are a multitude of known sequences to choose the “probe” of the claimed invention from, and one skilled in the art would know how to make and use the claimed invention in view of the state of the prior art and the instant disclosure together. Likewise, the rejection for lack of written description is withdrawn because possession is adequately demonstrated when considering the instant disclosure in view of the state of the prior art. New objections and rejections necessitated by amendment are set forth. Claim Objections Claim 1 is objected to because of the following informalities: the drawings of the structures appear lighter than the surrounding text and will make them difficult to reproduce. 37 C.F.R. 1.84 states “Character of lines, numbers, and letters. All drawings must be made by a process which will give them satisfactory reproduction characteristics. Every line, number, and letter must be durable, clean, black (except for color drawings), sufficiently dense and dark, and uniformly thick and well-defined.” Appropriate correction is required. 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 1, 2, 9, and 22-26 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. PNG media_image1.png 249 458 media_image1.png Greyscale The claims are indefinite over the illustration of the bond pointed to by an arrow. It is not clear if this is intended to illustrate that the attachment is at any position on the ring? This sort of attachment is typically illustrated by this: The instant drawing is indefinite PNG media_image2.png 149 286 media_image2.png Greyscale because it is unclear if the intent is to indicate variable attachment or if the attachment is meant to be at the carbon to the right of the vertical line. This should be clarified on the record either by adjusting the drawing or explaining the intent with clarity. In claims 22 and 26 the phrase “molecular weight” is indefinite. The recitation “molecular weight” is indefinite because a person of ordinary skill in the art would not understand with reasonable certainty to which type of molecular weight the claim language is referring. Teva Pharms. USA, Inc. v. Sandoz, Inc., 789 F.3d 1335 (Fed. Cir. 2015), held that the term “molecular weight” in several polymer claims was indefinite, because the term could mean either peak average molecular weight, number average molecular weight, or weight average molecular weight. Therefore, without a clear indication of how the molecular weight is measured the claimed term is indefinite. MPEP 2173.02 II. In claims 22-26 the phrase “the crowding agent” lacks antecedent basis because the claim does not recite or require a crowding agent. Claim 1 is free of the prior art. MacLean (IDS 11/16/21) teaches preparation of a biotinyl-tetrafluorobenzoyl-lysne group as a label for nucleotide based compounds. The compounds in part (a) of present claim 1 are different from these at least by the nature of the fluorescent moiety, which in the claims is FAM or DNP. Even if it were obvious to attach one of these to a biotin, the prior art does not suggest attaching this structure to a probe comprising a single stranded DNA, nor does the prior art suggest combining such a probe in a composition with formamidopyrimidine DNA glycosylase as currently required. 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. Any inquiry concerning this communication or earlier communications from the examiner should be directed to Juliet Switzer whose telephone number is (571)272-0753. The examiner can normally be reached Monday to Thursday, 8:00 AM-3:30 PM. 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, Winston Shen can be reached at (571)-272-3157. 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. Juliet Switzer Primary Examiner Art Unit 1682 /JULIET C SWITZER/Primary Examiner, Art Unit 1682
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Prosecution Timeline

Show 17 earlier events
May 28, 2025
Final Rejection mailed — §112
Nov 20, 2025
Examiner Interview Summary
Nov 26, 2025
Request for Continued Examination
Dec 01, 2025
Response after Non-Final Action
Mar 06, 2026
Non-Final Rejection mailed — §112
May 22, 2026
Response Filed
Sep 10, 2026
Final Rejection mailed — §112
Oct 23, 2026
Response after Non-Final Action

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Study what changed to get past this examiner. Based on 5 most recent grants.

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Prosecution Projections

8-9
Expected OA Rounds
42%
Grant Probability
96%
With Interview (+54.0%)
3y 8m (~0m remaining)
Median Time to Grant
High
PTA Risk
Based on 516 resolved cases by this examiner. Grant probability derived from career allowance rate.

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