Prosecution Insights
Last updated: September 17, 2026
Application No. 18/351,020

ANALYTE INSPECTION APPARATUS AND ANALYTE INSPECTION METHOD USING SAME

Non-Final OA §102§112
Filed
Jul 12, 2023
Priority
Jan 14, 2021 — RE 10-2021-0005516 +2 more
Examiner
HERON, VELVET ELIZABETH
Art Unit
1798
Tech Center
1700 — Chemical & Materials Engineering
Assignee
Aligned Genetics Inc.
OA Round
1 (Non-Final)
44%
Grant Probability
Moderate
1-2
OA Rounds
7m
Est. Remaining
94%
With Interview

Examiner Intelligence

Grants 44% of resolved cases
44%
Career Allowance Rate
8 granted / 18 resolved
-20.6% vs TC avg
Strong +49% interview lift
Without
With
+49.2%
Interview Lift
resolved cases with interview
Typical timeline
3y 10m
Avg Prosecution
26 currently pending
Career history
68
Total Applications
across all art units

Statute-Specific Performance

§101
2.1%
-37.9% vs TC avg
§103
48.3%
+8.3% vs TC avg
§102
29.0%
-11.0% vs TC avg
§112
19.9%
-20.1% vs TC avg
Black line = Tech Center average estimate • Based on career data from 18 resolved cases

Office Action

§102 §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 . Election/Restrictions Applicant's election with traverse of analyte inspection apparatus (Group I, claims 1-14) in the reply filed on May 22, 2026 is acknowledged. The traversal is on the ground(s) that the Examiner's search of Group I is likely to provide a proper search for Group II, and examination of Group II will not present an undue burden. This is not found persuasive because Group II would require an additional search in at least CPC B01L 3/50273 along with a unique text search including inspection chamber. The requirement is still deemed proper and is therefore made FINAL. Claims 15-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected analyte inspection method (Group II), there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on May 22, 2026. 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 applicant regards as his invention. Claims 1-14 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. Claim 1 recites “the plurality of compartments” in line 9. There is lack of antecedent basis for this limitation in the claim. The limitation will be interpreted as “a plurality of compartments separated by the one or more partition walls” for clarity. Claims 2-14 are rejected as being dependent on claim 1. Claim 1 recites “wherein the exchange flow path is configured to communicate with any one of the plurality of compartments separated by the one or more partition walls depending on a position of the piston”. The limitation “configured to” renders the limitation indefinite since it is unclear whether the exchange flow path is arranged to communicate with the compartment(s) in the claimed apparatus, or is merely designed to communicate with the compartment(s) but not required to. The limitation will be interpreted as “wherein the exchange flow path is in communication with any one of the plurality of compartments separated by the one or more partition walls depending on a position of the piston” for clarity. Claims 2-14 are rejected as being dependent on claim 1. 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. Claims 1-14 are rejected under 35 U.S.C. 102 (a)(1) as being anticipated by Koh et. al. (WO 2020213930 A1, already of record; see English translation). Regarding claim 1, Koh teaches “An analyte inspection apparatus comprising:” (FIGS. 1 and 2, the analyte collection device 10); “a body portion having one side open” (FIGS. 1 and 2, case 100); “and a main space in which a sample is accommodated” (Page 4 and FIGS. 1 and 2, space 102, sample accommodated in the inner space); “a piston” (FIGS. 1 and 2, piston 200) “including one or more partition walls partitioning the main space” (Fig. 2, partition wall 230) “and the piston being inserted into the main space of the body portion to be movable back and forth” (Page 4, piston inserted and provided to be reciprocally moved); “and an exchange flow path” (Fig. 5 cohesive groove 120). The recitation “configured to provide a passage for the sample to flow, wherein the exchange flow path is configured to communicate with any one of the plurality of compartments” is a capability taught by Koh (Page 6, four compartments 102a, 102b, 102c, and 102d); “separated by the one or more partition walls depending on a position of the piston.” (Page 6, In addition, the inner space 102 of the case 100 may be divided into a plurality of compartments by the partition wall 230 of the piston 200 to be described later.) Regarding claim 2, Koh teaches all of claim 1 as above. The recitation “wherein at least one of the plurality of compartments is provided to be filled with a solution for purifying an analyte in the sample.” is an intended use of the apparatus. Regarding claim 3, Koh teaches all of claim 1 as above in addition to “wherein the exchange flow path is formed to have one side communicating with the main space,” (Page 8, The cohesive groove 120 is concave formed from the inner wall surface forming the inner space 102); The recitation “and wherein the sample accommodated in the main space is configured to flow from the main space to the exchange flow path by a pressure difference applied to a discharge part” is recited as a capability of the sample within the main space. Koh teaches all of the positively claimed features including the discharge part (discharge port 140) and therefore is capable of performing the claimed function. The recitation “the discharge part being configured to communicate with an outside.” (Page 9, The discharge port 140 is formed to communicate with the outside). Regarding claim 4, Koh teaches all of claim 1 as above in addition to “wherein the body portion includes an exchange hole” (Fig. 5 opening of cohesive groove 120); “through which the analyte flows into the exchange flow path (Page 8, the cohesive groove 120 may be formed on the same line as the injection hole 112. Alternatively, at least the first compartment 102a may be formed at a position within a range in which the cohesive groove 120 and the injection hole 112 can communicate simultaneously. Accordingly, it is possible for the sample injected through the injection hole 112 to be directly accommodated): “and an opening” (injection hole 112); “through which the main space is exposed to an outside,” (Page 7, The sample injection unit 110 may include an injection hole 112 formed in the case 100 to communicate the inner space 102 and the outside of the case 100); “and wherein the exchange hole and the opening are formed at positions to communicate with each other through the main space partitioned by the partition wall.” (Page 8 and Figs. 1 and 2, In addition, the cohesive groove 120 may be formed on the same line as the injection hole 112.) Regarding claim 5, Koh teaches all of claim 1 as above in addition to “wherein the body portion includes a protruding part” (Figs. 1 and 2, closed part of case 100); “protruding from an end opposite to an end into which the piston is inserted, and wherein an insertion space is formed in the protruding part to insert at least a portion of the piston.” (Figs. 1 and 2) Regarding claim 6, Koh teaches all of claim 5 as above in addition to “wherein the body portion includes a blowback part” (blowback unit 130) which is provided at a position spaced apart from the protruding part by a predetermined distance and through which the main space communicates with an outside of the body portion.” (Page 9 and 8, The blowback part 130 is provided at an end opposite to the side into which the piston 200 is inserted, and includes a flow hole 132 formed so that both ends communicate with the inner space. Further, the blowback part 130 may be formed on the upper surface of the case 100, but the spirit of the present invention is not limited thereto, and may be formed on the side or the bottom surface of the case 100. When the piston 200 advances toward the blowback part 130 by the blowback part 130, gas such as air existing in the fourth compartment 102d is blown back through the flow hole 132. Accordingly, the purified analyte existing in the third compartment 102c may be discharged through the outlet 140 and collected into a collection container (X, see FIG. 3 ). Regarding claim 7, Koh teaches all of claim 6 as above in addition to “wherein the blowback part includes: a blowback inlet configured to serve as a passage through which fluid in the main space is discharged; a blowback outlet configured to serve as a passage through which fluid flows into the main space; and a bridge which extends in a direction in which the piston moves and through which the blowback inlet and the blowback outlet communicate with each other.” (Page 9, the flow hole 132 includes a flow hole inlet 1322, a bridge 1324 and a flow hole outlet 1326. Both the flow hole inlet 1322 and the flow hole outlet 1326 are formed so that one end communicates with the inner space 102, and each other end is connected through a bridge 1324, so that the flow hole 132 as a whole is' It can be formed as a U'-shaped channel. In this case, the flow hole inlet 1322 may be formed closer to the end opposite to the opening of the inner space 102 than the flow hole outlet 1326. ) Regarding claim 8, Koh teaches all of claim 6 as above in addition to “wherein the body portion includes an outlet” (Page 9, outlet 140) “through which the analyte is discharged from the body portion” (Page 4, the analyte inspection system may be provided in which the analyte is discharged through the outlet by a blowback phenomenon.). The recitation “after reacting with the solution in the main space and having undergone a predetermined treatment process,” refers to a method of operation of the claimed apparatus and has been interpreted as an intended use of the claimed apparatus. Koh teaches all of the positive recited features and therefore is capable of performing the claimed function. Koh further teaches “and wherein the outlet is formed at a position spaced apart from the protruding part by a predetermined distance and opposite to the blowback part.” (Figs. 1 and 2). Regarding claim 9, Koh teaches all of claim 8 as above in addition to the capability recitation “wherein the piston is configured to move into the insertion space to block between the insertion space and the main space and” (Figs 4a-j, shows movement of the piston). The recitation “the gas in the main space is configured to be blown back to push the analyte accommodated in the main space to the outlet.” is recited as a capability of the gas. Koh teaches all of the positive recited features and is therefore capable of blowing gas from the main space to push the analyte to the outlet. Regarding claim 10, Koh teaches all of claim 5 as above in addition to “wherein the piston further includes a central pillar” (Page 10, central pillar 210); and a piston head protruding from one end of the central pillar,” (Page 10 and Figs. 1 and 2, The central pillar 210 may be provided in a cylindrical shape, for example, and is provided to connect the piston head 220 and the partition wall 230.) and wherein the piston head is selectively inserted into the insertion space according to a movement of the central pillar.” (Figs 1 and 2). Regarding claim 11, Koh teaches all of claim 10 as above in addition to “wherein the one or more partition walls includes a plurality of partition walls (Page 7, one of the plurality of partitions 230), and wherein the plurality of partition walls extend radially from a circumferential surface of the central pillar and are spaced apart from each other in a direction in which the central pillar moves” (Figs 1 and 2). Regarding claim 12, Koh teaches all of claim 10 as above in addition to, “wherein the piston further includes: a head sealing member” (sealing member 250) configured to block between the insertion space and the main space by sealing a space between an inner circumferential surface of the protruding part and the piston head when the piston head is inserted into the insertion space; and a partition wall sealing member (sealing member 250) provided on an outer circumferential surface of the partition wall to prevent leakage of the solution between the partition wall and the body portion.” (Figs. 1 and 2). Regarding claim 13, Koh teaches all of claim 12 as above in addition to, “wherein the body portion includes a blowback part” (Page 7, blowback unit 130) “which is provided at a position spaced apart from the protruding part by a predetermined distance and through which the main space communicates with an outside of the body portion,” (Page 8 and 9, The blowback part 130 is provided at an end opposite to the side into which the piston 200 is inserted, and includes a flow hole 132 formed so that both ends communicate with the inner space. Further, the blowback part 130 may be formed on the upper surface of the case 100, but the spirit of the present invention is not limited thereto, and may be formed on the side or the bottom surface of the case 100. When the piston 200 advances toward the blowback part 130 by the blowback part 130, gas such as air existing in the fourth compartment 102d is blown back through the flow hole 132. Accordingly, the purified analyte existing in the third compartment 102c may be discharged through the outlet 140 and collected into a collection container (X, see FIG. 3 ); wherein the piston head has a head groove recessed from an outer circumferential surface of the piston head, (Page 10 and Fig. 2, flange 240); wherein the head sealing member is interposed in the head groove, (Fig. 2). The recitation is capability of the head groove and piston “and wherein the head groove is formed at a position spaced apart from one end of the piston head by a predetermined distance so that the insertion space, the main space, and the blowback part communicate with each other even when at least a portion of the piston head is inserted into the insertion space.”. Koh teaches all of the positively claimed features and therefore is capable of performing the claimed function. Regarding claim 14, Koh teaches all of claim 2 as above in addition to, “wherein one of the one or more partition walls is disposed between the compartments adjacent to each other among the plurality of compartments,” (Figs. 1 and 2). The recitation “and wherein in each of the plurality of compartments, a predetermined solution is filled or the sample is injected, and each of the plurality of compartments performs a predetermined function based on the predetermined solution or the sample” is intended use of the compartments and is being interpreted as a capability of the claimed apparatus. Koh teaches all of the positively recited features and therefore is capable of performing the claimed function (Figs. 1 and 2). Conclusion Any inquiry concerning this communication or earlier communications from the examiner should be directed to VELVET E HERON whose telephone number is (571)272-1557. The examiner can normally be reached 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, Charles Capozzi can be reached on (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. /V.E.H./Examiner, Art Unit 1798 /CHARLES CAPOZZI/Supervisory Patent Examiner, Art Unit 1798
Read full office action

Prosecution Timeline

Jul 12, 2023
Application Filed
Aug 27, 2026
Non-Final Rejection mailed — §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
44%
Grant Probability
94%
With Interview (+49.2%)
3y 10m (~7m remaining)
Median Time to Grant
Low
PTA Risk
Based on 18 resolved cases by this examiner. Grant probability derived from career allowance rate.

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