Prosecution Insights
Last updated: April 19, 2026
Application No. 18/115,382

POLYMERASE CHAIN REACTION (PCR) DIAGNOSIS APPARATUS

Non-Final OA §102§112
Filed
Feb 28, 2023
Examiner
TURK, NEIL N
Art Unit
1798
Tech Center
1700 — Chemical & Materials Engineering
Assignee
ELECTRONICS AND TELECOMMUNICATIONS RESEARCH INSTITUTE
OA Round
1 (Non-Final)
51%
Grant Probability
Moderate
1-2
OA Rounds
3y 11m
To Grant
96%
With Interview

Examiner Intelligence

Grants 51% of resolved cases
51%
Career Allow Rate
381 granted / 745 resolved
-13.9% vs TC avg
Strong +45% interview lift
Without
With
+44.9%
Interview Lift
resolved cases with interview
Typical timeline
3y 11m
Avg Prosecution
50 currently pending
Career history
795
Total Applications
across all art units

Statute-Specific Performance

§101
3.1%
-36.9% vs TC avg
§103
35.3%
-4.7% vs TC avg
§102
21.3%
-18.7% vs TC avg
§112
38.2%
-1.8% vs TC avg
Black line = Tech Center average estimate • Based on career data from 745 resolved cases

Office Action

§102 §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. Election/Restrictions Applicant’s election without traverse of Group I, claims 1-10, in the reply filed on March 11 th , 2026 is acknowledged. Claims 11-20 are withdrawn from consideration. Claim Interpretation 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. This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are: 1) PCR chip configured to store a PCR sample as in cl. 1 2) Light source part configured to generate laser light…as in cl. 1. 3) Code generator…configured to transmit an orthogonal code…as in cl. 1 Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof. 1) A sample holder , and equivalents thereof, as seen in pars.[ 0039,0043,0052], fig. 5 of Applicant’s pre-grant publication US 2023/0408410) 2) At least one laser light source or LED source*** and equivalents thereof (see pars.[0006,0010,0039,0058]), however, clarification is required with respect to the choice of LED source. 3) Those elements and equivalents thereof as seen through pars.[0005,0039,0048,0050]. If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. Further, with regard to the preamble of the claims drawn to “A PCR diagnosis apparatus,” no patentable weight is attributed to the preamble as the body of the claim is absent both PCR and diagnostic equipment therewith, and thus the preamble merely presents a statement of intended use. MPEP 2111.02 II. 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 appl icant regards as his invention. Claims 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 applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention. As discussed above, the recitation “light source part configured to generate laser light…” as in claim 1 is interpreted under 35 USC 112 F/6 th . The disclosure as in pars. [0006,0010,0039,0058] discusses constituent structure as at least one laser source or LED, however, the provision to an LED is not clearly understood. The functionality provided to the light source part is a configuration to generate laser light, wherein an LED’s providing of laser light renders the metes and bounds unclear. Does Applicant intend to recite that the light source part is configured to generate light, and subsequently in a dependent claim limit this light to laser light? For purposes of Examination at this time, both lasers and LEDs will be said to meet the recitation of the “light source part configured to generate laser light…” Claim Rejections - 35 USC § 102 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 ( i.e., changing from AIA to pre-AIA ) 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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action: A person shall be entitled to a patent unless – (a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale , or otherwise available to the public before the effective filing date of the claimed invention. Claim(s) 1 , 2, and 10 is/are rejected under 35 U.S.C. 102 a1 as being anticipated by Treptow et al. (US 2010/0324834), hereafter Treptow . With regard to claim 1, Treptow discloses a device and method for radiometric measurement of a plurality of samples (abstract). With regard to claim 1, Treptow discloses a PCR diagnosis apparatus comprising a PCR chip 5 [Examiner notes that ‘PCR’ is drawn to a nominal designation of the chip, wherein the chip itself does not provide any functionality besides holding and no particular PCR assay functionality] including receptacles 50/51 (i.e. the PCR chip is a well plate) , a light source part configured to generate a laser light to be provided to the PCR sample (i.e. comprised of a plurality of LEDs 31, 32, 33, 37 ; and wherein a plurality of lasers are also applicable as in par.[0067 ,0143 ] ), an optical modulator 34 (circuitry substrate to activate the LEDs) , a sensor 6 (and including elements 60-63) configured to detect fluorescent light generated in the PCR sample by the laser light, and a code generator 2 connected between the optical modulator and the sensor and configured to transmit an orthogonal code to the optical modulator and the sensor (the sample radiations from all samples are distinguishable from each other by utilizing multiplexing techniques in implementing at least one of FDMA, CDMA, TDMA, WDMA or phase multiplexing methods and the control device is adapted to use a spread-spectrum code to generate the modulation signals and modulated by a specific code sequence taken from a set of orthogonal code sequences such as Hadamard code and the like (pars.[ 0124,0179,0229 -0230 , 0266, 0342-0346, 0350 ,0367 ] , figs. 1-3 , 14, for example) . Examiner further notes that Treptow discloses the chip holder 5 can comprise the thermoblock of a thermocycles which can be used for PCR (pars.[0110,0179]). With regard to claim 2, Treptow discloses that the light source part comprises a first laser source configured to generate a first laser light and a second laser source connected (i.e. by common mounting) to the first laser light source and configured to generate second laser light having a longer wavelength than a wavelength of the first laser light(i.e. several light sources of different spectra are mounted in parallel to provide a broad spectrum in that from relatively short/high energy to relatively long/low energy wavelengths, and Treptow discloses modulation provided by WDMA to modulate the radiation sources at different wavelengths; pars.[0073,0074,0235,0261] . With regard to claim 10, Treptow discloses wherein the light source part comprises a plurality of laser diodes or light emitting diodes (pars.[0067,0143]), and further comprises optical fibers between the laser diodes or the light emitting diodes and the optical modulator and an optical fiber coupler (which is implicit given the discussion to optical fibers connected to the laser diodes/LEDs 31, 32, 33, 37 in order for the interfacing thereof such that radiation is input and passed therethrough) between the optical fibers and the optical modulator (par.[ 0373, 0374] , fig s . 1, 16, wherein the radiation that is emitted by the laser diodes/LEDs is input to and directed by means of a respective optical fiber to thereby interrogate the sample containers 205 , thus providing optical fibers between the modulator 34 (which is upstream of the emitters) and the laser diodes/LEDs 31,32,33,37 . Allowable Subject Matter Claims 3-9 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims. Claims 3-9 would be allowable if rewritten or amended to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA), 2nd paragraph, set forth in this Office action. The following is a statement of reasons for the indication of allowable subject matter: The prior art of record, namely Treptow , Muendel , Seo, Lee, Chandra , Christel, Ostuka (see further discussion below within the ‘Conclusion’ section to the cited prior art), does not teach or fairly suggest the apparatus as in claim 3 (and those further elements recited in combination therewith as by related dependent claims 4-9) to that of a semiconductor saturable absorber mirror connected to one side of the first optical fiber and a volume Bragg grating provided to another side of the first optical fiber. Conclusion The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Muendel et al. (US 2020/0412081) discloses a fiber-coupled laser light source with a semiconductor saturable mirror absorber, a pump light source and connected fiber optics, as well as a volume Bragg grating that enables pulse stretching contemporaneous with outcoupling that is pertinent to the missing features of the cited art of Treptow above and those additional prior art cited herein below, but whose disclosure is not analogous in nature to the cited prior art and those herein below and in which motivation to modify the cited prior art is not found. Seo et al. (US 2022/0064702) discloses an apparatus and method for PCR diagnosis based on a multi-wavelength light source and utilizing a code generator to modulate the light source to particularly control and optically investigate the DNA sample, which is relevant to Applicant’s field of endeavor. Lee et al. (US 2020/0011734 ) discloses a spectroscopic apparatus and method thereof using orthogonal codes to particularly modulate different light source channels to spectroscopically investigate a sample, which is relevant to Applicant’s field of endeavor. Chandra (US 2013/0101983) discloses a non-contact real time micro PCR system with a chip comprising a reaction chamber for holding a sample and an embedded heater therebelow , as well as an optical unit comprising an LED driver and photodetector to detect fluorescence emission from the sample in the reaction chamber, and wherein the heater is provided with a signal condition to regulate power to the induction heater based on feedback from an infrared temperature sensor, which is considered relevant to Applicant’s field of endeavor. Christel et al. (USPN 6,369,893) discloses a multi-channel optical detection system that includes a plurality of LEDs for investigating a DNA sample and fluorescence therefrom at a corresponding plurality of emission detectors in connection with PCR in which control logic is configured to adjust the brightness of the LEDs during operation, which is relevant to Applicant’s field of endeavor. Otsuka et al. (JP 2010078559) discloses a fluorescence analyzer that modulates light by different modulation modes , as in by provided orthogonal codes, that are capable of separating fluorescence signals from a plurality of interrogated samples within a holder and including first and second laser sources configured to provide a first relatively shorter wavelength and a second relatively longer wavelength, respectively, and wherein the modulated excitation light is conducted through an optical fiber and coupling portion, which is relevant to Applicant’s field of endeavor. Any inquiry concerning this communication or earlier communications from the examiner should be directed to FILLIN "Examiner name" \* MERGEFORMAT NEIL N TURK whose telephone number is FILLIN "Phone number" \* MERGEFORMAT (571)272-8914 . The examiner can normally be reached FILLIN "Work Schedule?" \* MERGEFORMAT M-F 930-630 . 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 Charles Capozzi can be reached at FILLIN "SPE Phone?" \* MERGEFORMAT 571-270-3638 . 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. /NEIL N TURK/ Primary Examiner, Art Unit 1798
Read full office action

Prosecution Timeline

Feb 28, 2023
Application Filed
Mar 27, 2026
Non-Final Rejection — §102, §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
51%
Grant Probability
96%
With Interview (+44.9%)
3y 11m
Median Time to Grant
Low
PTA Risk
Based on 745 resolved cases by this examiner. Grant probability derived from career allow rate.

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