Prosecution Insights
Last updated: April 19, 2026
Application No. 18/560,380

DNA AND RNA NUCLEIC ACID CO-EXTRACTION AND DETECTION SYSTEM

Non-Final OA §112
Filed
Nov 11, 2023
Examiner
EDWARDS, LYDIA E
Art Unit
1796
Tech Center
1700 — Chemical & Materials Engineering
Assignee
Autobio Labtec Instruments Co. Ltd.
OA Round
1 (Non-Final)
60%
Grant Probability
Moderate
1-2
OA Rounds
3y 9m
To Grant
64%
With Interview

Examiner Intelligence

Grants 60% of resolved cases
60%
Career Allow Rate
419 granted / 700 resolved
-5.1% vs TC avg
Minimal +4% lift
Without
With
+4.1%
Interview Lift
resolved cases with interview
Typical timeline
3y 9m
Avg Prosecution
36 currently pending
Career history
736
Total Applications
across all art units

Statute-Specific Performance

§101
0.1%
-39.9% vs TC avg
§103
49.1%
+9.1% vs TC avg
§102
20.6%
-19.4% vs TC avg
§112
22.3%
-17.7% vs TC avg
Black line = Tech Center average estimate • Based on career data from 700 resolved cases

Office Action

§112
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. Information Disclosure Statement The information disclosure statement s (IDS) submitted on 11/11/2023 and 05/02/2025 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement s are being considered by the examiner. Drawings The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the control system of claim 1 must be shown or the feature(s) canceled from the claim(s). No new matter should be entered. Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance. Claim Objections Claim 7 is objected to because of the following informalities: line 3 recites “an cover opening assembly”. I t appears that line 3 should read “a cover opening assembly”. Appropriate correction is required. 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. 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) are: a control system in claim s 1 , 11 and 14-20 , a consumable supply module in claim s 1 , 11 and 14-20 , a kit loading module claims 1, 11 and 14-20 , a scanning assembly in claim 3, a pusher assembly in claim 3, a pusher moving assembly in claim 3, a detection assembly in claim s 3 and 10 , a driving assembly in claim 4, a heating assembly in claim 5, a heat-dissipation assembly in claim 5, a rotating assembly in claim 6, a gripper assembly in claim s 7 and 8 , a cover opening assembly in claim 7, a retraction drive assembly in claim 8, an amplification cooling assembly in claim 9, a light source assembly in claim 10, a fluorescence detection assembly in claim 10, a gantry assembly in claim s 11 and 14-20 , a pricking control assembly in claim 12, a pipetting control assembly in claim 12, a reagent needle lifting assembly in claim 12, a reagent needle translation assembly in claim 12, a pipette pump lifting assembly in claim 13, and a plunger lifting assembly in claim 13 . Because this claim limitation(s) is being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it is being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof. A review of the specification shows that the following appears to be the corresponding structure described in the specification for the 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph limitati on: Consumable Supply Module: a disposable tip consumable box 12, a PCR consumable box and a sealing plug ( applicant’s specification at paragraph 0 0 32) , Scanning Assembly: a reflector and a code reader ( applicant’s at specification paragraph 00 50 ) , Pusher Assembly: a linear displacement mechanism, a driving mechanism, and a pusher (applicant’s specification at paragraph 0051) , Pusher Moving Assembly: a linear displacement mechanism and a driving mechanism (applicant’s specification at paragraph 0049) , Detection Assembly: a scanning reset senso r (applicant’s specification at paragraph 0059), Driving Assembly: a variety of driving mechanisms such as a lead-screw driving mechanism and a guide rail driving mechanism (applicant’s specification at paragraph 0063), Rotating Assembly: a synchronous belt mechanism and a rotating motor (applicant’s specification at paragraph 0083), Gripper Assembly: a gripper base plate, a gripper movable plate , a gripper and a retraction drive assembly (applicant’s specification at paragraph 0125), Gantry Assembly: a gantry and a sample adding moving assembly , e.g., a driving motor, a hydraulic cylinder, or an electric push rod (applicant’s specification at paragraph s 0094 and 0096 ), Pricking Control Assembly: a linear displacement mechanism and a driving mechanism. The linear displacement mechanism may specifically include a guide-rail and slider mechanism, a guide column and guide sleeve structure, and so on. The driving mechanism may specifically include an electrical driving mechanism such as a lead-screw motor, a step motor, a hydraulic cylinder, and an electric push rod (applicant’s specification at paragraph 0102), Reagent Needle Lifting Assembly: a linear displacement mechanism such as a guide-rail and slider mechanism, a synchronous belt mechanism, and a driving mechanism such as a step motor (applicant’s specification at paragraph 010 4 ), Reagent Needle Translation Assembly: a linear displacement mechanism such as a guide-rail and slider mechanism, a synchronous belt mechanism, and a driving mechanism such as a step motor (applicant’s specification at paragraph 010 4 ), Pipette Pump Lifting Assembly: a linear displacement mechanism and a driving mechanism. The linear displacement mechanism includes a guide-rail and slider mechanism, a synchronous belt mechanism and so on, and the driving mechanism includes a step motor, a lead-screw motor, a hydraulic cylinder, an electric push rod and so on (applicant’s specification at paragraph 0112), Plunger Lifting Assembly: a linear displacement mechanism and a driving mechanism. The linear displacement mechanism includes a guide-rail and slider mechanism, a synchronous belt mechanism and so on, and the driving mechanism includes a step motor, a lead-screw motor, a hydraulic cylinder, an electric push rod and so on (applicant’s specification at paragraph 0112) . If A pplicant 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, s ixth 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. Claim Rejections - 35 USC § 112 The following is a quotation of the first paragraph of 35 U.S.C. 112(a): (a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention. The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112: The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention. 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. 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. As explained above, c laim limitations “a control system”, “a kit loading module”, “a heating assembly”, “a heat-dissipation assembly” , “a cover opening assembly”, “a retraction drive assembly”, “an amplification cooling assembly”, “a light source assembly”, “a fluorescence detection assembly”, “a pipetting control assembly” invoke 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. However, the written description fails to disclose the corresponding structure, material, or acts for performing the entire claimed function and to clearly link the structure, material, or acts to t he function. Therefore , claims 1 , 7-10 and 1 2 are rejected under 35 U.S.C. § 112(a) as failing to comply with the written description requirement, and under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention. Claims 2-6, 11 and 13-20 depend on independent claim 1 and are therefore rejected for the same reason. Applicant may: (a ) Amend the claim so that the claim limitation will no longer be interpreted as a limitation under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph; (b ) Amend the written description of the specification such that it expressly recites what structure, material, or acts perform the entire claimed function, without introducing any new matter (35 U.S.C. 132(a)); or (c ) Amend the written description of the specification such that it clearly links the structure, material, or acts disclosed therein to the function recited in the claim, without introducing any new matter (35 U.S.C. 132(a)). If applicant is of the opinion that the written description of the specification already implicitly or inherently discloses the corresponding structure, material, or acts and clearly links them to the function so that one of ordinary skill in the art would recognize what structure, material, or acts perform the claimed function, applicant should clarify the record by either: (a ) Amending the written description of the specification such that it expressly recites the corresponding structure, material, or acts for performing the claimed function and clearly links or associates the structure, material, or acts to the claimed function, without introducing any new matter (35 U.S.C. 132(a)); or (b ) Stating on the record what the corresponding structure, material, or acts, which are implicitly or inherently set forth in the written description of the specification, perform the claimed function. For more information, see 37 CFR 1.75(d) and MPEP §§ 608.01(o) and 2181. Conclusion Any inquiry concerning this communication or earlier communications from the examiner should be directed to FILLIN "Examiner name" \* MERGEFORMAT LYDIA EDWARDS whose telephone number is FILLIN "Phone number" \* MERGEFORMAT (571)270-3242 . The examiner can normally be reached on FILLIN "Work Schedule?" \* MERGEFORMAT Monday- Wedne sday 08 : 0 0- 18 : 0 0 EST . 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, Curtis Mayes can be reached on FILLIN "SPE Phone?" \* MERGEFORMAT 571- 272- 1234 . The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300. Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000. /LYDIA EDWARDS/ Primary Examiner, Art Unit 1796
Read full office action

Prosecution Timeline

Nov 11, 2023
Application Filed
Apr 01, 2026
Non-Final Rejection — §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
60%
Grant Probability
64%
With Interview (+4.1%)
3y 9m
Median Time to Grant
Low
PTA Risk
Based on 700 resolved cases by this examiner. Grant probability derived from career allow rate.

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