DETAILED ACTION
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.
Claim 1 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Lansing (US 20180311664).
Lansing discloses a test device comprising a detection chamber (Figure 1:118) that includes a testing element (Figure 1:130) configured to test an analyte in a liquid sample. A sample collector (Figure 1:120) that includes an absorption element (Figure 1:124) and a handle (Figure 1:122) is additionally provided. The test device further includes an accommodating chamber (Figure 1:140) configured to accommodate the absorption element of the sample collector and a docking area (Figure 1:116) configured to accommodate the handle of the sample collector. This is described in paragraphs [0046]-[0057]. Lansing shows in Fig. 2 that the absorption element is stored in the accommodating chamber before it is removed to absorb a liquid sample. After the absorption element absorbs the liquid sample, it is reinserted into the accommodating chamber for testing, and the handle is reinserted back into the docking area. See Figs. 4-6.
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 2-6, 16-18 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Lansing (US 20180311664) as applied to claim 1, and further in view of Liu (CN 21409174) and/or Sun (US 6372516).
Lansing discloses the apparatus as described above. Lansing further teaches that the absorption element 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 through a throat portion (Figure 8:188) of the test element. This compresses the absorption element and causes the release of the liquid sample onto the sample application area. Although Lansing discloses a testing element, it is unclear if Lansing states that the testing element 130 includes a sample application area and a label area separate from the testing area.
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. 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.
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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. 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. 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. 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.
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”). 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.
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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”). 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. 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). 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.
Before the effective filing date of the claimed invention, it would have been obvious to ensure that the Lansing testing element is characterized by distinct sample application, label and testing areas. Liu and Sun indicate that this is a standard feature of prior art test strips, and that the application, label and testing areas each operate according to a predictable and specialized function. Liu and Sun teach that test strips perform important disease diagnosis according to various detection means, and that it is often necessary to include multiple immunoreagents at specific locations that are optically accessible. It is prima facie obvious to applying a known technique to a known device ready for improvement to yield predictable result. See MPEP 2143.
Allowable Subject Matter
Claims 7-15 and 19 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. Lansing, Sun and Liu are believed to be the closest prior art for the reasons expressed above, however do not appear to disclose the required insertion and/or pressurizing means required by the claims.
Applicant’s remarks and amendment filed 11 June 2026 are sufficient to overcome the prior art. The Guirguis (US 7741103), Lavarack (US 20200114348) and Loudermilk (US 20200376483) references additionally disclose the state of the art regarding testing devices, but suffer from the same deficiencies as the other previously cited references.
Response to Arguments
In response to Applicant’s amendment filed 11 June 2026, a new ground of rejection is made in view of the Lansing reference.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NATHAN ANDREW BOWERS whose telephone number is (571)272-8613. The examiner can normally be reached M-F 7am-5pm.
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/NATHAN A BOWERS/Primary Examiner, Art Unit 1799
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