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 .
Priority
The present application was filed on 06/23/2023. The effective filing date of this instant
application is 06/23/2023.
Information Disclosure Statement
An additional Information Disclosure Statement (IDS), filed 05/26/2026, is acknowledged and considered. In this additional IDS, filed on 05/26/2026, Applicant submission of missing NPL documents originally listed in, but missing from, the IDS filed on 03/18/2025 are acknowledged, considered, and accepted.
Claim Status
Claims 1-10 are pending. Claims 11-20 are cancelled. Claims 1-10 are examined herein below.
Claim Rejections - 35 USC § 103
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 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.
Claim(s) 1-10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Zhao et al., (CN Patent No. 10396943, Date: 01/29/2013), in view of Fiechtner et al., (PGPub No. US 20210148906A1, Pub. Date: 05/20/2021).
Throughout the disclosure, Zhao teaches a lateral flow device for collecting and testing biological samples, including saliva, blood, urine, serum, plasma, tears, semen, and bone marrow (see para 0022). The device comprises of upper and lower cards and support structures on the lower card for supporting test elements. Additionally, Zhao teaches a portion of each support structure that supports the sample application pad as being inclined (see Fig. 1, label 207). Each test element comprises of a sample application pad, label pad, testing pad, and a liquid sample diversion element. Each test element is positioned on the support structure with an inclined end (see paras 0023 and 0026). Zhao further teaches that two test elements located in the same device are positioned in parallel and horizontally (Fig. 1 and para 0023, lines 5-6). Zhao also teaches the upper card is provided with a pressing pin (Figs. 2, component labeled 205) while the lower card comprises an enclosure around the inclined portions of the support structures (Fig. 1, component labeled 203 corresponds to one wall of the enclosure).
Regarding claim 1, Zhao teaches a device for testing an analyte in a liquid sample, comprising: a housing comprising an upper card and a lower card (Zhao et al., CN10396943: Fig. 1 and para 0020), wherein a supporting structure for supporting a lateral flow testing element is arranged on the lower card (Zhao et al., CN10396943: Fig. 1 and para 0020), the lateral flow testing element is configured to test the analyte in the liquid sample (Zhao et al., CN10396943: para 0022), and comprises a sample application pad for receiving the liquid sample (Zhao et al., CN10396943: Figure 1, label 301 and para 20), the supporting structure comprises a supporting structure for supporting the entire sample application pad (Zhao et al., CN10396943: Fig. ,1 label 207 and para 20), and a part of the supporting structure for supporting the sample application pad is inclined (Zhao et al., CN10396943: Figs. 1 and 3, inclined sample pad label 301). Zhao does not teach a protruding fixing pin configured to secure sample application pad closely attached to an inclined portion of the supporting structure.
Fiechtner teaches a lateral flow assay device for detecting an analyte of interest in a liquid sample. The device comprises a housing with an upper card and a lower card (Fiechtner et al., US 20210148906A1: para 0070). The upper card comprises a sample dripping hole and is located in the sample receiving area (paras 0070-0071). Fiechtner teaches the upper card comprises structures positioned in various locations along the interior side, which function as one or more compression points that can secure a sample application pad closely the sample pad supporting structure and that can confine and retain the liquid sample to prevent flooding, leaking, and/or overflowing of the liquid sample (paras 0072-0073 and Fig. 4A, structural components labeled 306). Fiechtner further teaches that compression points, structural components labeled 306, may be positions in various points along the upper card and are not limited to the particular shape, number or arrangement disclosed (para 0072). Fiechtner teaches the lower card comprises support structures in select positions that interact with the structures in the upper card that would function as one or more diversion strips on two sides of a sample application hole (para 0073).
Fiechtner teaches the limitation(s) of claim 1 reciting wherein the upper card further comprises a protruding fixing pin configured to keep the sample application pad closely attached to an inclined plane of the part of the supporting structure ((Fiechtner et al., US 20210148906A1: paras 0072-0073, 0075; Fig. 4A, structural components labeled 306 capable of functioning as protruding fixing point; and Figs. 3A-B, structural component labeled 214, functioning as sample application pad).
It would have been prima facie obvious, at the time of filing, to combine the device for testing an analyte in a liquid sample, as taught by Zhao, with the compression point capable of functioning as a protruding fixing pin taught by Fiechtner. A skilled artisan would have been motivated to combine these teachings because it would enable the device for testing an analyte to secure the sample application pad; ensure the sample application pad remains in close contact with the inclined plane of the supporting structure; and prevent liquid sample leakage, flooding, or overflowing. A skilled artisan would be further motivated to combine these teachings because the shape of the compression point taught by Fiechtner would have minimal contact with the sample application pad while securing it closely to the supporting structure while not obstructing direction of capillary flow of the liquid sample. Fiechtner teaches one or more compression points and various locations. A skilled artisan would have been further motivated to try the finite number of options for number of compression points (protruding fixing pin) and locations taught and suggested by Fiechtner to arrive at the claimed invention as part of routine optimization. At the time of filing, a person having ordinary skill in the art would have a reasonable expectation of success because combining these known teachings, known to perform the same function separately as they do when combined, would yield expected and predictable results. Additionally, at the time of filing, a skilled artisan would have been further motivated to combine these teachings and performing routine optimization by trying the finite number of known/identified number of compression points (solutions) and locations to arrive at the claimed invention, would yield expected and predictable results.
Regarding claim 2, Zhao and Fiechtner teach all the limitations of claim 1. Zhao further teaches the device according to claim 1, wherein the lateral flow testing element further comprises a label pad (Zhao et al., CN10396943: Fig. 5, label 302 and para 0023), and a testing pad (Zhao et al., CN10396943: Fig. 5 and para 0023), wherein the label pad is located downstream of the sample application pad for receiving the liquid sample (Zhao et al., CN10396943: Fig. 3, labels 301 [application pad]-302 [label pad]; paras 0023 and 0031), and the other part of the supporting structure for supporting the sample application pad and a supporting structure for supporting the label pad are located in a substantially horizontal position (Zhao et al., CN10396943: para 0023; Figs. 1, 3 and 4).
Regarding claim 3, Zhao and Fiechtner teach all the limitations of claim 1. Zhao further teaches the device according to claim 2, wherein a position of the inclined supporting structure is lower than that of the supporting structure for supporting the label pad (Zhao et al., CN10396943: Fig. 1, label 207 corresponds to supporting structure with lower inclined portion and higher supporting portion and Fig. 3, label 302 corresponds to label pad located downstream of 301, the application pad).
Regarding claim 4, Zhao and Fiechtner teach all the limitations of claim 1. Zhao further teaches the device according to claim 3, wherein the lateral flow testing element comprises a first lateral flow testing element (Zhao et al., CN10396943: Fig. 1 and para 0023) having a first sample receiving pad (Zhao et al., CN10396943: Figs. 1, and 3-5, label 301), and a second lateral flow testing element having a second sample receiving pad (Zhao et al., CN10396943: Fig. 1, label 310 is top of second sample receiving pad and para 0023, lines 5-6 ), wherein part of the inclined structure for supporting the sample application pad comprises a first inclined supporting structure (Zhao et al., CN10396943: Fig. 1 label 207) and a second inclined supporting structure (Zhao et al., CN10396943: Fig. 1, second inclined supporting structure identical to and next to label 207); and part of the first sample receiving pad covers the first inclined supporting structure (Zhao et al., CN10396943: Fig. 1 labels 207 and 311), and part of the second sample receiving pad covers the second inclined supporting structure (Zhao et al., CN10396943: Fig. 1, second identical sample receiving pad next to label 207 and second identical inclined support structure next to 207).
Regarding claim 5, Zhao and Fiechtner teach all the limitations of claim 1. Zhao further teaches the device according to claim 4, wherein the first inclined supporting structure and the second inclined supporting structure are spaced apart in parallel (Zhao et al., CN10396943: Fig. 1, label 207 and second, identical support structure next to it).
Regarding claim 6, Zhao and Fiechtner teach all the limitations of claim 1. Zhao further teaches the device according to claim 5, further comprising a liquid diversion element made of a water absorbent material (Zhao et al., CN10396943: Fig. 1, structures labeled 400-402; Fig. 3, structures labeled 401 and 402; and paras 0006, 0020, and 0026), wherein the liquid diversion element covers the part of the first sample receiving pad (Zhao et al., CN10396943: Fig. 3, labels 301 and 401-402) and the part of the second sample receiving pad (Zhao et al., CN10396943: Fig. 1, liquid divergent element [labeled 400-402] over first sample pad [para 23, Fig. 3, labeled 301] comprising of a sample receiving area [Fig. 1, labeled 311]; and second sample pad [Fig. 1], comprising a second sample receiving area [a component of sample receiving area labeled 310]).
Regarding claim 7, Zhao and Fiechtner teach all the limitations of claim 1. Zhao further teaches the device according to claim 6, wherein the lower card further comprises a liquid sample diversion area (Zhao et al., CN10396943: Fig. 1, labeled 203, one sidewall of the liquid diversion area), the first inclined supporting structure and the second inclined supporting structure are located in the liquid sample diversion area (Zhao et al., CN10396943: Fig. 1, to left side of component 203 are two inclined structures), and the first inclined supporting structure and the second inclined supporting structure are distributed at two ends of the liquid sample diversion area (Zhao et al., CN10396943: Fig. 1).
Regarding claim 8, Zhao and Fiechtner teach all the limitations of claim 1. Claims 6 and 7, from which claim 8 depends on, disclose the liquid diversion element is stacked vertically on the sample receiving area of the sample pad. The instant Specification further clarifies that “the liquid diversion element covers the sample receiving area” (Zhao et al., CN10396943: para 14). Zhao further teaches the device according to claim 7, wherein the liquid diversion element is parallel to the first inclined supporting structure and the second inclined supporting structure or also obliquely arranged (Zhao et al., CN10396943: Fig. 1, structure labeled 400-402 and two identical inclined supporting structures, one inclined structure is labeled 207).
Regarding claim 9, Zhao and Fiechtner teach all the limitations of claim 1. Zhao further teaches the device according to claim 7, wherein a liquid sample receiving area is arranged at the center of the liquid diversion element and located between the first inclined supporting structure and the second inclined supporting structure (Zhao et al., CN10396943: Fig. 3, components labeled 301 [sample receiving area] and 401-402 [liquid diversion element] ).
Regarding claim 10, Zhao and Fiechtner teach all the limitations of claim 1. Zhao further teaches the device according to claim 6, wherein the liquid sample diversion area comprises a low-lying area, and liquid from the liquid diversion element obliquely arranged is capable of flowing to the low-lying area for collection (Zhao et al., CN10396943: Fig. 1, open area between the two inclined support structures in front of label 203).
Response to Arguments
Applicant’s arguments, filed on 05/26/2026, with respect to the rejections of claims 1-10 under 35 U.S.C. 102(a)(1)/(a)(2) have been fully considered. Consideration of Applicant’s arguments and amendments made to independent claim 1 necessitated a new ground of rejection that does not rely solely on the reference applied in the prior rejection of record for the teaching or matter specifically challenged in the argument, rendering Applicant’s arguments moot.
Conclusion
All examined claims (1-10) are rejected. No claims are allowed.
THIS ACTION IS MADE FINAL. 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 MELISSA L LIRIANO-NG whose telephone number is (571)272-0085. The examiner can normally be reached Monday-Friday, 7:30 am-3:30 pm (EST).
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/MELISSA LIZETTE LIRIANO-NG/Examiner, Art Unit 1677
/BAO-THUY L NGUYEN/Supervisory Patent Examiner, Art Unit 1677 June 15, 2026
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