Prosecution Insights
Last updated: April 19, 2026
Application No. 18/102,031

NUCLEIC ACID AMPLIFICATION PROCESSES

Final Rejection §112§DP
Filed
Jan 26, 2023
Examiner
BERTAGNA, ANGELA MARIE
Art Unit
1681
Tech Center
1600 — Biotechnology & Organic Chemistry
Assignee
Lumiradx UK Ltd.
OA Round
2 (Final)
44%
Grant Probability
Moderate
3-4
OA Rounds
4y 1m
To Grant
90%
With Interview

Examiner Intelligence

Grants 44% of resolved cases
44%
Career Allow Rate
310 granted / 701 resolved
-15.8% vs TC avg
Strong +46% interview lift
Without
With
+46.1%
Interview Lift
resolved cases with interview
Typical timeline
4y 1m
Avg Prosecution
27 currently pending
Career history
728
Total Applications
across all art units

Statute-Specific Performance

§101
5.1%
-34.9% vs TC avg
§103
36.2%
-3.8% vs TC avg
§102
13.4%
-26.6% vs TC avg
§112
32.4%
-7.6% vs TC avg
Black line = Tech Center average estimate • Based on career data from 701 resolved cases

Office Action

§112 §DP
DETAILED ACTION Notice of Pre-AIA or AIA Status 1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA . Status of the Application 2. Applicant’s response filed on January 16, 2026 has been entered. Claims 1, 32-37, 39, 40, and 48 are pending and under examination. The following objections and rejections have been withdrawn as being obviated by Applicant’s response, which includes a substitute specification, claim amendments, and the submission of a proper terminal disclaimer over US 11,591,643: (1) the objections to the substitute specification; (2) the objections to claims 1, 32, 35, and 41-43; (3) the rejection of claims 1 and 32-50 under 35 U.S.C. 112(a) (new matter); (4) the rejection of claims 1 and 32-40 under 35 U.S.C. 112(b); (5) the rejection of claim 38 under 35 U.S.C. 112(d); and (6) the non-statutory double patenting rejections citing US 11,591,643. The objection to the abstract made previously has been maintained because it is not addressed by the response and remains applicable. Applicant’s remarks do not address this objection. With the exception of the aforementioned objection to the abstract, the following are new grounds of objection are necessitated by the amendment. Terminal Disclaimer 3. The terminal disclaimer filed on January 16, 2026 disclaiming the terminal portion of any patent granted on this application which would extend beyond the expiration date of U.S. Patent No. 11,591,643 has been reviewed and is accepted. The terminal disclaimer has been recorded. Substitute Specification 4. Applicant’s submission of a substitute specification on January 16, 2026 is acknowledged. The substitute specification has been entered. The substitute specification is objected to because the new version of Table 2 on page 34 of the marked-up copy of the substitute specification is missing the heading “STAR Conditions.” The substitute specification is also objected to because the new version of Table 4 on page 36 of the marked-up copy of the substitute specification recites “STAR” and “Temperature” as column headings rather than “STAR Conditions” and “Temperature Decrease”. Appropriate correction is required. Specification 5. The abstract of the disclosure is objected to because it is more than 150 words in length. As discussed in MPEP 608.01(b), the abstract should be no more than 150 words in length. A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP 608.01(b). Claim Interpretation 6. The following is a quotation of 35 U.S.C. 112(f): (f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof. The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph: An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof. The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked. As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph: (A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function; (B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and (C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function. Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function. Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function. Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. In this case, the terms “passive means” and “active and passive means” in claims 33 and 34 have been treated as invoking 35 U.S.C. 112(f). The specification discloses passive means for cooling as thermal radiation from the reaction mixture (page 16). The following are disclosed in the specification as active means for cooling: a fan, a cooling fluid (e.g., a chilled water bath) that can be contacted with the reaction mixture, a cooled environment, a reaction-compatible coolant, or a Peltier-type cooling device (page 19). Claim Objections 7. Claim 1 is objected to because “single stranded” in step (a) should be hyphenated. Claim 1 also contains a typographical error in step (d) where “steps (c) and (d)” is recited for “steps (b) and (c).” Claims 32-37, 39, 40, and 48 are also objected to by way of their dependency on claim 1. Claim 36 is also objected to because the word “of” is missing after the word “range” in line 2. Conclusion 8. No claims are currently allowable. The claims remain free of the prior art for the reasons set forth in the last Office action. THIS ACTION IS MADE FINAL. 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 Angela Bertagna whose telephone number is (571)272-8291. The examiner can normally be reached 8-5, M-F. 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, Gary Benzion can be reached at 571-272-0782. 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. /ANGELA M. BERTAGNA/Primary Examiner, Art Unit 1681
Read full office action

Prosecution Timeline

Jan 26, 2023
Application Filed
Oct 10, 2025
Non-Final Rejection — §112, §DP
Jan 16, 2026
Response Filed
Feb 17, 2026
Final Rejection — §112, §DP (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
44%
Grant Probability
90%
With Interview (+46.1%)
4y 1m
Median Time to Grant
Moderate
PTA Risk
Based on 701 resolved cases by this examiner. Grant probability derived from career allow rate.

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