Prosecution Insights
Last updated: April 18, 2026
Application No. 17/246,972

METHODS FOR QUANTITATIVE AMPLIFICATION

Non-Final OA §103
Filed
May 03, 2021
Examiner
WOITACH, JOSEPH T
Art Unit
1687
Tech Center
1600 — Biotechnology & Organic Chemistry
Assignee
BIOMERIEUX
OA Round
1 (Non-Final)
49%
Grant Probability
Moderate
1-2
OA Rounds
4y 7m
To Grant
78%
With Interview

Examiner Intelligence

Grants 49% of resolved cases
49%
Career Allow Rate
187 granted / 381 resolved
-10.9% vs TC avg
Strong +28% interview lift
Without
With
+28.5%
Interview Lift
resolved cases with interview
Typical timeline
4y 7m
Avg Prosecution
71 currently pending
Career history
452
Total Applications
across all art units

Statute-Specific Performance

§101
35.0%
-5.0% vs TC avg
§103
18.7%
-21.3% vs TC avg
§102
4.2%
-35.8% vs TC avg
§112
25.4%
-14.6% vs TC avg
Black line = Tech Center average estimate • Based on career data from 381 resolved cases

Office Action

§103
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. Priority This application filed 5/3/2021 is a divisional of 16/087724 filed 9/24/2018 , now US Patent 11,268141 which is a 371 national stage filing of PCT/US17/23151 filed 3/20/2017 which claims benefit to US Provisional application 62/313032 filed 3/24/2016. It is noted that in review of the parent application ‘724, the non-elected method claims were cancelled, and the claims in the instant case are duplicates of those cancelled (claims 21-39) and this appears to be a proper divisional. Claim Status Original claims 1-10 filed 5/3/2021 are pending. Request under 37 CFR 1. 33 The request filed 2/6/2025 has been accepted (see paper entered 2/20/2025 ). Information Disclosure Statement The three information disclosure statement s (IDS) submitted on 5/3/2021 through 3/7/2023 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner. It is noted that for the IDS filed5/3/2021 refs #6, 7, 11/29/2022 ref #2 and 3/7/2023 ref #3 the office action and translation have been reviewed for what is provided, but there are no corresponding claims or context for what is provided or cited. The listing of references in the specification is not a proper information disclosure statement. See for example [0060]. 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609.04(a) states, "the list may not be incorporated into the specification but must be submitted in a separate paper." Therefore, unless the references have been cited by the examiner on form PTO-892, they have not been considered. Claim Rejections - 35 USC § 103 In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status. The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action: A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made. Claims 1-10 are rejected under 35 U.S.C. 103 as being unpatentable over Swiger et al. ( US 2005/0014176 A1), BIOFIRE D iagnotistics , (US 2015/0232916 A1), Guenin et al. (J Exp Bot v 60, n 2 2009) and Luu-The et al ( Biotechniques 38:287-293 Feb 2005) (all of record in IDS filed) . Swiger discloses a method of performing quantitative amplification on a sample (a novel method for quantitative analysis of the initial amount of target nucleic acids in a sample; paragraph [0011]), comprising amplifying the sample in an amplification mixture (PCR reaction mixtures; paragraph [0051]), the amplification mixture comprising a pair of target primers (the forward and reverse primers; paragraph [0051]) configured to amplify a target that may be present in the sample (PCR primers for the target nucleic acid sequence of the simulant pathogen; paragraph [0049]), the amplification mixture further comprising a plurality of quantification standard nucleic acids (multiplex standards; paragraph [0030]) each provided at a different known concentration (containing known starting amounts of each of the different nucleic acids are used; paragraph [0030]) and at least one pair of quantification standard primers (primers are selected to produce PCR amplification products of each of the different target nucleic acids; paragraph [0030]), the quantification standard primers configured to amplify quantification standard nucleic acids (primers are selected to produce PCR amplification products of each of the different target nucleic acids; paragraph [0030]), generating a standard curve from the quantification standard amplicons, and quantifying the target nucleic acid using the standard curve (the full range of standard from 10 femtograms to 10,000 femtograms and the unknown starting quantity of a target nucleic acid sample is derived by locating its elution peak area on the plot line and extrapolating the starting target quantity from the x-axis of the plot; paragraph [0058]). Swiger further discloses wherein the amplification mixture further comprises a plurality of additional pairs of target primers configured to amplify a plurality of additional targets that may be present in the sample (primers are selected to produce PCR amplification products of each of the different target nucleic acids; paragraph [0030]). Swiger discloses further comprising, subsequent to the amplifying step, dividing the amplification mixture into a plurality of individual reactions (quantitative plot of target nucleic acid standard dilution series for target; paragraph [0025]), a first group of the plurality of individual reactions each comprising a pair of primers configured to further amplify one of the different targets that may be present in the sample (primers are selected to produce PCR amplification products of each of the different target nucleic acids; paragraph [0030]), and a second group of the plurality of individual reactions each comprising a pair of primers configured to further amplify one of the quantification standard nucleic acids (the internal standard is different, it will require its own primers; paragraph [0040]), and subjecting the plurality of individual reactions to amplification conditions to generate one or more target amplicons and a plurality of quantification standard amplicons (a PCR amplification products resulting from said target nucleic acid and a standard; paragraph [0011]), wherein the generating and quantifying steps take place subsequent to the subjecting step. Swiger further discloses further comprising detecting amplification of each of the quantification standard nucleic acids using a label (fluorescent labeling of the primers may be used to allow PCR elution peak detection; paragraph [0035]) specific for that quantification standard nucleic acid (the internal standard is different, it will require its own primers; paragraph [0040]). Swiger further discloses wherein each of the plurality of internal quantification standard nucleic acids is provided to the amplification mixture (multiplex standards; paragraph [0030]) in known amounts to also serve as process controls (an internal standard may also be used; paragraph [0040]). Swiger discloses use of at least one sample processing control as a quantification standard in a method for quantifying a nucleic acid in a sample (multiplex standards; paragraph [0030]). Similar to Swiger, Biofire discloses a method for performing quantitative nucleic acid amplification on nucleic acid molecules in a sample (method for quantifying a target nucleic acid with a secondary PCR; paragraphs [0048], [0083]), comprising a) lysing said sample (a cell lysate; paragraph [0040]); b) extracting the nucleic acid molecules from said sample (DNA extraction; paragraph [0050]); c) performing nucleic acid amplification of the nucleic acid molecules (nucleic acid amplification; paragraph [0043]); wherein at least one sample processing control is added to said sample prior to step a) or during step a) in a known amount (a multiplexed PCR reaction is provided, containing a control nucleic acid at a known initial concentration; paragraph [0085]); characterized in that a nucleic acid sequence from the sample processing control serves as a quantification standard (the amplification of the control nucleic acid and the target nucleic acid produce an amplification curve; paragraph [0086]). Biofire discloses an instrument (the Film Array instrument; paragraph [0049]) for performing quantitative two-step PCR on a sample (method for quantifying a target nucleic acid with a secondary PCR; paragraphs [0048], [0083]), comprising an opening for receiving the sample vessel, a first heater for subjecting the amplification container to amplification conditions (a thermocycling element; paragraph [0092]), a second heater for subjecting the plurality of second-stage individual reaction wells to amplification conditions (thermocyclers; paragraph [0097]), a computer programmed to generate a standard curve using the amplification of the quantification standard nucleic acids and output a quantitative or semi-quantitative result for each amplified target (CPU may then generate an amplification curve, a melt curve, or any combination, which may or may not be printed, displayed on a screen, or otherwise outputted; paragraph [0096]). Biofire further discloses wherein the computer is further programmed to apply a correction factor to the standard curve for at least one of the targets (adjusted real-time PCR curves for the control and sample nucleic acids; paragraph [0036]). In all Biofire discloses a method of performing quantitative two-step amplification on a sample (method for quantifying a target nucleic acid with a secondary PCR; paragraphs [0048], [0083]), comprising amplifying the sample in a first-stage multiplex amplification mixture (the reagents are for nucleic acid extraction, first-stage multiplex PCR, dilution of the multiplex reaction; paragraph [0050]), the amplification mixture comprising a plurality of target primers (primers for amplifying a locus from a different one of the plurality of target nucleic acid sequence; paragraph [0008]), each target primer configured to amplify a different target that may be present in the sample (primers for amplifying a locus from a different one of the plurality of target nucleic acid sequence; paragraph [0008]), dividing the first-stage amplification mixture into a plurality of second-stage individual reactions (after first-stage PCR was complete, the mixture was diluted and was transferred to each of the second-stage wells; paragraph [0061]), a first group of the plurality of second-stage individual reactions each comprising at least one primer configured to further amplify one of the different targets that may be present in the sample (and each of the 102 second-stage wells is pre-loaded with a specific PCR primer pair; paragraph [0055]), subjecting the plurality of second-stage individual reactions to amplification conditions to generate one or more target amplicons (second-stage PCR; paragraph [0054), and each quantification standard amplicon having an associated quantification standard Cp (the true positive amplified much earlier with a Cp between 7.9 and 8.0; paragraph [0062]). Biofire does not disclose the amplification mixture comprising a plurality of internal quantification standard nucleic acids each provided at a different known concentration and at least one quantification standard primer, the quantification standard primer configured to amplify quantification standard nucleic acids, and a second group of the plurality of second-stage individual reactions each comprising at least one primer configured to further amplify one of the quantification standard nucleic acids, and a plurality of quantification standard amplicons. However, Swiger does disclose the amplification mixture comprising a plurality of internal quantification standard nucleic acids (multiplex standards; paragraph [0030]) each provided at a different known concentration (containing known starting amounts of each of the different nucleic acids are used; paragraph [0030]) and at least one quantification standard primer (primers are selected to produce PCR amplification products of each of the different target nucleic acids; paragraph [0030]), the quantification standard primer configured to amplify quantification standard nucleic acids (primers are selected to produce PCR amplification pr oducts of each of the different target nucleic acids; paragraph [0030]), and a second group of the plurality of second-stage individual reactions each comprising at least one primer configured to further amplify one of the quantification standard nucleic acids (primers are selected to produce PCR amplification products of each of the different target nucleic acids; paragraph [0030]), and a plurality of quantification standard amplicons (multiplex standards; paragraph [0030]). Guenin et al. and Luu-The et al are provided for further evidence of the knowledge and context for the use of quatitative PCR and the use of standards in calculations to derive a standard curve (Ct) to establish the concentration of a target of interest in the sample. I n view of the art as whole as evidenced by Swiger et al. , BIOFIRE D iagnotistics , Guenin et al. and Luu-The et al , it would have been obvious to one of ordinary skill in the art at the time of the invention to modify the Biofire invention to provide the amplification mixture comprising a plurality of internal quantification standard nucleic acids each provided at a different known concentration and at least one quantification standard primer, the quantification standard primer configured to amplify quantification standard nucleic acids, and a second group of the plurality of second-stage individual reactions each comprising at least one primer configured to further amplify one of the quantification standard nucleic acids, and a plurality of quantification standard amplicons, as taught by Swiger, in order to provide a more convenient reaction mix. Conclusion No claim is allowed. Any inquiry concerning this communication or earlier communications from the examiner should be directed to FILLIN "Examiner name" \* MERGEFORMAT Joseph T Woitach whose telephone number is FILLIN "Phone number" \* MERGEFORMAT (571)272-0739 . The examiner can normally be reached FILLIN "Work Schedule?" \* MERGEFORMAT Mon-Fri; 8:00-4:00 . 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, FILLIN "SPE Name?" \* MERGEFORMAT Karlheinz R Skowronek can be reached at FILLIN "SPE Phone?" \* MERGEFORMAT 571 272-9047 . 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. /Joseph Woitach/ Primary Examiner, Art Unit 1687
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Prosecution Timeline

May 03, 2021
Application Filed
Apr 01, 2026
Non-Final Rejection — §103 (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
49%
Grant Probability
78%
With Interview (+28.5%)
4y 7m
Median Time to Grant
Low
PTA Risk
Based on 381 resolved cases by this examiner. Grant probability derived from career allow rate.

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