Prosecution Insights
Last updated: April 19, 2026
Application No. 18/037,282

APPARATUS AND METHODS FOR MOLECULAR DIAGNOSTICS

Non-Final OA §102§103
Filed
May 16, 2023
Examiner
KRCHA, MATTHEW D
Art Unit
1796
Tech Center
1700 — Chemical & Materials Engineering
Assignee
Nuclein LLC
OA Round
1 (Non-Final)
66%
Grant Probability
Favorable
1-2
OA Rounds
3y 3m
To Grant
99%
With Interview

Examiner Intelligence

Grants 66% — above average
66%
Career Allow Rate
358 granted / 544 resolved
+0.8% vs TC avg
Strong +36% interview lift
Without
With
+35.6%
Interview Lift
resolved cases with interview
Typical timeline
3y 3m
Avg Prosecution
71 currently pending
Career history
615
Total Applications
across all art units

Statute-Specific Performance

§101
1.6%
-38.4% vs TC avg
§103
47.8%
+7.8% vs TC avg
§102
21.9%
-18.1% vs TC avg
§112
22.9%
-17.1% vs TC avg
Black line = Tech Center average estimate • Based on career data from 544 resolved cases

Office Action

§102 §103
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 . Election/Restrictions Applicant’s election without traverse of Group I in the reply filed on 1/5/2026 is acknowledged. Claims 15-20, 30, 39, 40 and 42 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. 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) 13 and 14 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by United States Patent No. 9,096,892, hereinafter Klemer. Regarding claim 13, Klemer teaches an apparatus for nucleic acid detection (abstract), the apparatus comprising: a light source (item 17) configured to illuminate a chamber (item 8) (figure 6); a power source (item 200) configured provide an electric current to the light source (column 7, lines 39-42); a control system (items 40, 62, 68 and 70) configured to control the electric current provided to the light source (column 7, lines 34-36); and a light detector (item 37) configured to detect a light signal from the chamber (column 7, lines 50-56), wherein the control system is configured to automatically calibrate the amount of electric current provided to the light source (column 7, lines 43-47). Regarding claim 14, Klemer teaches further comprising one or more nucleic acids (column 3, lines 29-41). Claim Rejections - 35 USC § 103 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. The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows: 1. Determining the scope and contents of the prior art. 2. Ascertaining the differences between the prior art and the claims at issue. 3. Resolving the level of ordinary skill in the pertinent art. 4. Considering objective evidence present in the application indicating obviousness or nonobviousness. This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention. Claim(s) 9-12 and 36 is/are rejected under 35 U.S.C. 103 as being unpatentable over Klemer in view of WO 2007/019509, hereinafter Washburn. Regarding claim 9, Klemer teaches an apparatus for nucleic acid detection (abstract), the apparatus comprising: a light source (item 17) configured to illuminate a chamber (item 8) (figure 6); a power source (item 200) configured provide an electric current to the light source (column 7, lines 39-42); a control system (items 40, 62, 68 and 70) configured to control the electric current provided to the light source (column 7, lines 34-36); and a light detector (item 37) configured to detect a light signal from the chamber (column 7, lines 50-56), wherein the control system comprises a detection circuit with a transimpedance amplifier (column 6, lines 56-59). Klemer fails to teach the detection circuit has a T-network for defining gain using a transimpedance amplifier. Washburn teaches a photodetection device which utilizes a transimpedance amplifier with a Tee resistor network (Washburn, paragraph [0013] and figure 2) which provides electronic circuit designers to realize wider useable bandwidth and faster large signal response in high gain, feedback amplifiers than is achieved using classic feedback network configurations (Washburn, paragraph [0025]). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have utilized a detection circuit has a T-network for defining gain using a transimpedance amplifier instead of a standard transimpedance amplifier because it provides electronic circuit designers to realize wider useable bandwidth and faster large signal response in high gain, feedback amplifiers than is achieved using classic feedback network configurations (Washburn, paragraph [0025]). Regarding claim 10, modified Klemer teaches the transimpedance amplifier with gain defined by a T-network feedback resistor configuration comprises: a first resistor (R200), a second resistor (R202) and third resistor (R201). Klemer and Washburn fail to specifically teach the resistance values of the three resistors. Washburn further teaches the values for resistors R200 and R201 maybe chosen or estimated based upon required amplifier performance characteristics and then adjusted as part of a design optimization and the values of resistors R200 and R202 are approximately equal (Washburn, paragraph [0030]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, to determine, through routine experimentation, the optimum resistance values of the first, second and third resistor to a 50 kiloohms, 50, kiloohms and 10 kiloohms, respectively, which would allow for the required amplifier performance characteristics and then adjusted as part of a design optimization (Washburn, paragraph [0030]) (MPEP § 2144.05 (II)). Regarding claim 11, Klemer and Washburn teach all limitations of claim 9; however, they fail to teach the transimpedance amplifier with gain defined by a T-network feedback resistor configuration has an equivalent functional resistance between 0.1-1000 megaohm. Washburn further teaches the values for resistors R200 and R201 maybe chosen or estimated based upon required amplifier performance characteristics and then adjusted as part of a design optimization and the values of resistors R200 and R202 are approximately equal (Washburn, paragraph [0030]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, to determine, through routine experimentation, the optimum equivalent functional resistance to be between 0.1-1000 megaohm which would allow for the required amplifier performance characteristics and then adjusted as part of a design optimization (Washburn, paragraph [0030]) (MPEP § 2144.05 (II)). Regarding claim 12, Klemer teaches further comprising one or more nucleic acids (column 3, lines 29-41). Regarding claim 36, Klemer teaches the control system comprises a detection circuit with a transimpedance amplifier (column 6, lines 56-59). Klemer fails to teach a variable gain element. Washburn teaches a photodetection device which utilizes a transimpedance amplifier with a variable gain Tee resistor network (Washburn, paragraph [0013] and figure 3) which provides electronic circuit designers to realize wider useable bandwidth and faster large signal response in high gain, feedback amplifiers than is achieved using classic feedback network configurations (Washburn, paragraph [0025]). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have utilized a detection circuit has a T-network with variable gain using a transimpedance amplifier instead of a standard transimpedance amplifier because it provides electronic circuit designers to realize wider useable bandwidth and faster large signal response in high gain, feedback amplifiers than is achieved using classic feedback network configurations (Washburn, paragraph [0025]). Claim(s) 37 and 38 is/are rejected under 35 U.S.C. 103 as being unpatentable over Klemer in view of KR 102022198, hereinafter Chung. Regarding claim 37, Klemer teaches all limitations of claim 13; however, Klemer fails to teach the control system is configured to control the electric current provided to the light source between a range of about 0.5 amperes and about 15 amperes. Chung teaches a detection device which has a light source in which the operating voltage and current are adjusted so that the brightness of the light source can be adjusted (Chung, pages 4-5, last paragraph – first paragraph). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, to determine, through routine experimentation, the optimum electric current provided to the light source to a range of 0.5-15 amperes which would allow for the desired brightness of the light source (Chung, pages 4-5, last paragraph – first paragraph) (MPEP § 2144.05 (II)). Regarding claim 38, Klemer teaches all limitations of claim 13; however, Klemer fails to teach the control system is configured to control the electric current provided to the light source at a duration of less than about 25 milliseconds. Chung teaches a detection device which has a light source in which pulse width modulation with a relay is applied to the light source so that the brightness of the light source can be adjusted (Chung, pages 4-5, last paragraph – first paragraph). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have utilized pulse width modulation with a relay on the light source so that the brightness of the light source can be adjusted (Chung, pages 4-5, last paragraph – first paragraph). Further, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, to determine, through routine experimentation, the optimum duration of the pulses (duration of applying current) to less than about 25 milliseconds which would allow for the desired brightness of the light source (Chung, pages 4-5, last paragraph – first paragraph) (MPEP § 2144.05 (II)). Claim(s) 41 is/are rejected under 35 U.S.C. 103 as being unpatentable over Klemer in view of United States Application Publication No. 2004/0029258, hereinafter Heaney. Regarding claim 41, Klemer teaches all limitations of claim 13; however, Klemer fails to teach the control system is configured to control the rate at which contents of the chamber are heated is greater than 300°C-pL/s. Heaney teaches a detection device with nucleic acids in which the rate of cooling and heating determines the total processing time and increasing the heating rate shortens the total processing time of the reaction (Heaney, paragraph [0169]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, to determine, through routine experimentation, the optimum heating rate to be greater than 300°C-pL/s which would allow for shortening of the total processing times for the reaction (Heaney, paragraph [0169]) (MPEP § 2144.05 (II)). Conclusion Any inquiry concerning this communication or earlier communications from the examiner should be directed to MATTHEW D KRCHA whose telephone number is (571)270-0386. The examiner can normally be reached M-Th 7am-5pm. 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, Elizabeth Robinson can be reached at (571)272-7129. 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. /MATTHEW D KRCHA/ Primary Examiner, Art Unit 1796
Read full office action

Prosecution Timeline

May 16, 2023
Application Filed
Jan 26, 2026
Non-Final Rejection — §102, §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
66%
Grant Probability
99%
With Interview (+35.6%)
3y 3m
Median Time to Grant
Low
PTA Risk
Based on 544 resolved cases by this examiner. Grant probability derived from career allow rate.

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