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.
Claim Status
Claims 1-10 are pending. Claims 11-20 are cancelled. Claims 1-10 are examined herein below.
Information Disclosure Statement
Two Information Disclosure Statements (IDS), filed 06/23/2023 and 03/18/2025, are acknowledged and have been considered except for three NPL references that were stricken for the reasons detailed herein.
Document NPL Cite No. 39, Lee et al., while the 7-page supplemental information is provided, the full article is missing.
Document NPL Cite No. 40, Ki et al., while the 13-page supplemental information is provided, the full article is missing.
Document NPL Cite No. 41, Ki et al., while the 13-page supplemental information is provided, the full article is missing.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-10 are rejected under 35 U.S.C. 102(a)(1) and (a)(2) as being clearly anticipated by Zhao et al., CN Patent No. 103969433 A.
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, a liquid diversion element (Fig. 1, structures labeled 400-402) and a liquid sample diversion area (Fig. 1). 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).
Regarding claim 1, Zhao teaches a device for testing an analyte in a fluid sample, comprising: a housing comprising an upper card and a lower card (Fig. 1 and para 0020), wherein a supporting structure for supporting a lateral flow testing element is arranged on the lower card (Fig. 1 and para 0020), the lateral flow testing element is configured to test the analyte in the fluid sample (para 0022), and comprises an application pad for receiving the liquid sample (Figure 1, label 301 and para 20), the supporting structure comprises a supporting structure for supporting the entire sample application pad (Fig. ,1 label 207 and para 20), and a part of the supporting structure for supporting the sample application pad is inclined (Figs. 1 and 3, inclined sample pad label 301).
Regarding claim 2, Zhao teaches the device according to claim 1, wherein the lateral flow testing element further comprises a label pad (Fig. 5, label 302 and para 0023), and a testing pad (Fig. 5 and para 0023), wherein the label pad is located downstream of the application pad for receiving a liquid sample (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 (para 0023; Figs. 1, 3 and 4).
Regarding claim 3, Zhao 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 (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 teaches the device according to claim 3, wherein the lateral flow testing element comprises a first lateral flow testing element (Fig. 1 and para 0023) having a first sample receiving pad (Figs. 1, and 3-5, label 301), and a second lateral flow testing element having a second sample receiving pad (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 (Fig. 1 label 207) and a second inclined supporting structure (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 (Fig. 1 labels 207 and 311), and part of the second sample receiving pad covers the second inclined supporting structure (Fig. 1, second identical sample receiving pad next to label 207 and second identical inclined support structure next to 207).
Regarding claim 5, Zhao teaches the device according to claim 4, wherein the first inclined supporting structure and the second inclined supporting structure are spaced apart in parallel (Figure 1, label 207 and second, identical support structure next to it).
Regarding claim 6, Zhao teaches the device according to claim 5, further comprising a liquid diversion element made of a water absorbent material (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 (Fig. 3, labels 301 and 401-402) and the part of the second sample receiving pad (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 teaches the device according to claim 6, wherein the lower card further comprises a liquid sample diversion area (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 (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 (Fig. 1).
Regarding claim 8, 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” (para 14). Zhao 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 (Fig. 1, structure labeled 400-402 and two identical inclined supporting structures, one inclined structure is labeled 207).
Regarding claim 9, Zhao 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 (Fig. 3, components labeled 301 [sample receiving area] and 401-402 [liquid diversion element] ).
Regarding claim 10, Zhao 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 (Fig. 1, open area between the two inclined support structures in front of label 203).
Conclusion
All claims (1-10) in this instant application have been rejected. No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MELISSA L LIRIANO whose telephone number is (571)272-0085. The examiner can normally be reached Monday-Friday, 7:30 am- 4:30 pm (EST).
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/MELISSA LIZETTE LIRIANO/ Examiner, Art Unit 1677
/BAO-THUY L NGUYEN/Supervisory Patent Examiner, Art Unit 1677 February 23, 2026