Prosecution Insights
Last updated: April 19, 2026
Application No. 18/366,386

DEVICE FOR TESTING ANALYTE IN LIQUID SAMPLE

Non-Final OA §102§103§112
Filed
Aug 07, 2023
Examiner
BOWERS, NATHAN ANDREW
Art Unit
1799
Tech Center
1700 — Chemical & Materials Engineering
Assignee
Hangzhou Biotest Biotech Co. Ltd.
OA Round
1 (Non-Final)
59%
Grant Probability
Moderate
1-2
OA Rounds
3y 6m
To Grant
91%
With Interview

Examiner Intelligence

Grants 59% of resolved cases
59%
Career Allow Rate
796 granted / 1346 resolved
-5.9% vs TC avg
Strong +32% interview lift
Without
With
+32.2%
Interview Lift
resolved cases with interview
Typical timeline
3y 6m
Avg Prosecution
66 currently pending
Career history
1412
Total Applications
across all art units

Statute-Specific Performance

§101
0.2%
-39.8% vs TC avg
§103
54.3%
+14.3% vs TC avg
§102
14.3%
-25.7% vs TC avg
§112
16.7%
-23.3% vs TC avg
Black line = Tech Center average estimate • Based on career data from 1346 resolved cases

Office Action

§102 §103 §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. 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. Claims 6- 11 and 15 are rejected 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. With respect to claim 6, the term “the accommodating chamber ,is in the second state” is indefinite and appears to be missing at least one word. It is unclear what meaning is intended. With respect to claims 7-11 and 15, the metes and bounds of the term “jack” are unclear. The term is not defined by the specification , and it is not commonly used in the art. It is unclear if “jack” is used simply to refer to a generic port or receptacle. Claim 8 recites the limitation "the insertion element" in lines 2-3. There is insufficient antecedent basis for this limitation in the claim. It is believed that claim 8 should be dependent on claim 7. Claim 8 recites the limitation "the jack" in lines 3. There is insufficient antecedent basis for this limitation in the claim. It is believed that claim 8 should be dependent on claim 7. Claim Rejections - 35 USC § 102 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- 8, 10, 11, 15- 17 and 20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Liu (CN 214097174) . With respect to claim 1, Liu discloses a test device comprising a detection chamber having a lower cover (Figure 1:2) and an upper cover (Figure 1:1). A testing element (Figure 1:8) is disposed within the detection chamber and is configured to test an analyte in a liquid sample. The test device further includes a sample collector (Figure 1:3) comprising an absorption element (Figure 2:7) configured to absorb the liquid sample. An accommodating chamber (Figure 2:11) is provided on or in the test device and is configured to accommodate the absorption element of the sample collector. With respect to claim 2, Liu discloses the apparatus as described above. Liu shows that the testing element 8 includes a testing area and a sample application area, wherein a part of the sample application area is located in the accommodating chamber. With respect to claims 3-6 , Liu discloses the apparatus as described above. Liu further teaches that the absorption element 7 has a first state and a second state in the accommodating chamber. In the first state, the absorption element is not in direction contact with the sample application area of the testing element 8. In a second state, the absorption element is pressed on a pressing plate (Figure 5:16) of the sample application area of the test element. This compresses the absorption element and causes the release of the liquid sample onto the sample application area. With respect to claims 7, 8, 10, 11 and 15, Liu discloses the apparatus as described above. The Liu test device includes a frame 14 that receives the absorption element and functions as a jack. The absorption element is on the terminal end of the sample collector comprising a handle having a rod body 33 and a grip 32. The handle is received by a docking area 13 for accommodating the handle. When the handle is fixed in the docking area, the handle may be manipulated to apply a pressure to the carrier and cause the absorption element to be compressed. With respect to claim 16, Liu discloses the apparatus as described above. When the Liu absorption element is in the first state, the remainder of the sample collector (e.g., the handle) does not absorb the liquid sample. With respect to claim 17, Liu discloses the apparatus as described above. When the Liu absorption element is in the first state, the absorption element is protected by a cover body, such as the upper cover 1, the lower cover 2, and a frame 14. With respect to claim 20, Liu discloses the apparatus as described above. Liu further shows that the lower cover 2 and the upper cover 1 of the testing element have areas suitable for applying a label (i.e., a label area). A window area (Figure 1:12) is located at the testing area. Claims 1- 9 , 16, 17 and 20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Sun (US 6372516 ). With respect to claim 1, Sun discloses a test device comprising a detection chamber (Figure 1:10) comprising a test element (Figure 1:18) configured to test an analyte in a liquid sample. The test device further includes a sample collector comprising an absorption element (Figure 7:14) configured to absorb the liquid sample. An accommodating chamber is provided in the test device, such that the accommodating chamber is configured to accommodate the absorption element of the sample collector. This is shown in Fig. 13 and described in column 3, lines 33-50 (“ The cap 12 is then replaced over the holder 46 and is used to push or otherwise move the holder 46 back into the test device so that the absorbent pad 14 contacts the membrane 16 and the test strip 18 ”). With respect to claim 2, Sun discloses the apparatus as described above. Sun further teaches that the testing element comprises a testing area and a sample application area, wherein a part of the sample application area is located in the accommodating chamber. With respect to claims 3-6, Sun discloses the apparatus as described above. Sun further teaches that the absorption element 14 has a first state and a second state in the accommodating chamber. In the first state, the absorption element is not in direction contact with the sample application area of the testing element. In a second state, the absorption element is pressed by pressing plates (Figure 12:42 and Figure 12:44) as the absorption element is inserted into the sample application area. This compresses the absorption element and causes the release of the liquid sample onto the sample application area (“ The protrusion 66 on the holder 46 is used to further facilitate the absorbent pad 14 to contact the membrane 16. That is, protrusion 66 slides through the housing 20 until it contacts projection 42 and stop member 44. The action of the protrusion 66 contacting the projection 42 forces the absorbent pad 14 upward, thereby forcing the pad 14 to come into contact with the membrane 16 ”) . With respect to claims 7 and 8, Sun discloses the apparatus as described above. The Sun test device includes a port that receives the absorption element and functions as a jack and/or a docking area. With respect to claim 9, Sun discloses the apparatus as described above. Sun further states that an indicator strip (Figure 1:16) is in fluid communication with the absorption element 14 and is configured to indicate whether the adsorption element has fully absorbed a liquid sample (“ the membrane 16 indicates when a sufficient amount of sample has been collected which can be observed through window 30”) . With respect to claim 16, Sun discloses the apparatus as described above. When the Sun absorption element is in the first state, the remainder of the sample collector (e.g., the carrier 46) does not absorb the liquid sample. With respect to claim 17, Sun discloses the apparatus as described above. When the Sun absorption element is in the first state, the absorption element is protected by a cover body having a top half (Figure 11:22) and a bottom half (Figure 12:24). With respect to claim 20, Sun discloses the apparatus as described above. Sun further shows that the top half 22 and bottom half 24 of the testing element have areas suitable for applying a label (i.e., a label area). A window area (Figure 1:30 and Figure 1:32) is located at the testing area. Claims 1-8, 12-14, 16, 17 and 20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Eckermann (US 7294502 ). With respect to claim 1, Eckermann discloses a test device comprising a detection chamber, wherein the detection chamber includes a testing element (Figure 1:8) configured to test an analyte in a liquid sample. The test device further includes a sample collector comprising an absorption element (Figure 1:4) configured to absorb the liquid sample. An accommodating chamber is provided on in or in the test device, wherein the accommodating chamber is configured to accommodate the absorption element when the testing element transitions from a first state to a second state. This is shown in Figs. 1-3 and described in column 8, line 14 to column 9, line 15. With respect to claims 2-6, Eckermann discloses the apparatus as described above. Eckermann further shows that the testing element includes a testing area and a sample application area, such that part of the sample application area is located in the accommodating chamber. When the device is moved into the second state, the absorption element is pressed on the sample application area and compressed to release liquid sample onto the sample application area using a grating 11. With respect to claims 7 and 8, Eckermann discloses the apparatus as described above. The Eckermann test device includes a port in a holder 5 that receives the absorption element and functions as a jack and/or a docking area. With respect to claim s 12-14, Eckermann discloses the apparatus as described above. Eckermann teaches that a pressure element 11 is turned over to cover the accommodating chamber to apply a pressure to the absorption element and compress the absorption element via operation of a hinge 12. A window area 9 is hidden in a first configuration (see Figs. 1 and 2) and exposed in the second configuration (see Fig. 3). With respect to claim 16, Eckermann discloses the apparatus as described above. When the Eckermann absorption element is in the first state, the remainder of the sample collector (e.g., the holder 5 ) does not absorb the liquid sample. With respect to claim 17, Eckermann discloses the apparatus as described above. When the Eckermann absorption element is in the first state, the absorption element is protected by a cover body formed by the holder 5 . With respect to claim 20, Eckermann discloses the apparatus as described above. Eckermann further shows that the upper part 3 and lower part 2 of the testing element have areas suitable for applying a label (i.e., a label area). A window area (Figure 3:9 ) is located at the testing area. 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 . Claims 12-14, 18 and 19 are rejected under 35 U.S.C. 103 as being unpatentable over either Liu (CN 214097174) or Sun (US 6372516) each as applied to claims 1 and 3, and further in view of Gupta (US 20140187892), Kayyem (US 10495656) and Raj (US 20080020482) . Liu and Sun each teach the apparatuses as described above, however neither expressly teaches a pressure element comprising clamping parts and a rail, wherein the pressure element slides onto the accommodating chamber to apply a pressure to the absorption element. Gupta discloses a test device comprising a detection chamber having a testing element (Figure 6:28) disposed within an accommodating chamber (Figure 6:38). Liquid sample is moved into the accommodating chamber when a button (Figure 6:32) is activated by movement of a pressure element (Figure 6:30). The pressure element includes two clamping parts (Figure 6:31) that interact with a sliding rail or chute (Figure 3:36) to enable longitudinal movement of the pressure element. When the sliding element moves over the button, the button is released so that sample moves from the button to the accommodating chamber. The button is analogous to the claimed absorption element. Kayyem discloses a test device comprising a detection chamber having a testing element disposed within an accommodating chamber. Sample and reagents are moved into accommodating chamber using a pressure element configured to slide laterally via the interaction of clamping parts with a rail or chute. This is described in column 4, line 62 to column 5, line 10 and column 30, line 14 to column 31, line 22. Reagents and/or sample are retained in a compartment (Figure 3B:36) in a first state and moved to the accommodating chamber in a second state when the compartment is compressed by the pressure element as a platen (Figure 3B:64) is depressed during the sliding operation. Raj discloses a test device comprising a detection chamber having a testing element disposed within an accommodating chamber. Sample passes from an absorption element (Figure 1a:3) to the testing element to obtain a detectable result. A sliding pressure element (Figure 1b:6) comprising two clamping parts hides a window area (Figure 1b:4) in a first state and exposes the window area 4 when moved into a second state (compare Figs. 2a and 2b). Before the effective filing date of the claimed invention, it would have been obvious to provide the Liu and/or Sun test devices with an alternative pressure element configured as a slide that compresses the absorption element as it is moved from a first state to a second state. Gupta, Kayyem and Raj show how this sliding design is known in the test strip art and may be used to move fluid from a first initial location to a testing location in a predictable manner. Those of ordinary skill would have recognized that the provision of a slide would grant the operator greater manual control over when the sample is moved from the absorption element to the testing element to initiate detection, thereby allowing the test device to be pre-loaded while preventing unwanted and premature actuation. The slide mechanism may also provide a greater compressive force to ensure that a sufficient amount of sample is delivered from the absorption element to the testing element. Conclusion The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. The CN 105784443 reference teaches the state of the art regarding test devices comprising a testing element and an absorption element. Any inquiry concerning this communication or earlier communications from the examiner should be directed to FILLIN "Examiner name" \* MERGEFORMAT NATHAN ANDREW BOWERS whose telephone number is FILLIN "Phone number" \* MERGEFORMAT (571)272-8613 . The examiner can normally be reached FILLIN "Work Schedule?" \* MERGEFORMAT M-F 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, FILLIN "SPE Name?" \* MERGEFORMAT Michael Marcheschi can be reached at FILLIN "SPE Phone?" \* MERGEFORMAT (571) 272-1374 . 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. /NATHAN A BOWERS/ Primary Examiner, Art Unit 1799
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Prosecution Timeline

Aug 07, 2023
Application Filed
Mar 09, 2026
Non-Final Rejection — §102, §103, §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
59%
Grant Probability
91%
With Interview (+32.2%)
3y 6m
Median Time to Grant
Low
PTA Risk
Based on 1346 resolved cases by this examiner. Grant probability derived from career allow rate.

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