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 § 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 1-20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kim et al. (US 2015/0251177).
Regarding claim 1, Kim discloses a rapid test device for detecting a target analyte in a saliva sample, the rapid test device (fig. 8-11b) comprising:
an elongate housing (10/30 lower and upper case) forming an interior channel extending in a flow direction (see fig. 9-11b; the claim does not specifically state the flow direction is parallel to the length of the elongated housing. The flow direction as broadly interpreted can flow up and down and left to right);
a lateral flow test strip (20) for detecting the target analyte being accommodated in the elongate housing and extending along the channel in flow direction, wherein the lateral flow test strip includes a sample pad (21);
a saliva receiving port (32) at an end portion (an end portion is generally interpreted as the left side of the elongated housing) of the elongate housing configured to receive the saliva sample directly from a mouth of a user (this limitation does not further structurally limit the instant claim. Further a saliva sample is not positively recited and therefore is not part of the claim structures); and
a sample collection cavity (14/12) extending from the saliva receiving port in the flow direction for collecting the saliva sample received through the saliva receiving port (the sample is received at saliva receiving port 32 and then to sample collection cavity);
wherein the sample pad (21) of the lateral flow test strip extends into the sample collection cavity to receive saliva collected in the sample collection cavity.
Regarding claim 2, the rapid test device according to claim 1, wherein the elongate housing comprises at least one flow gate (fig. 11a, ref. 36a and portion 18 at area which protrudes up and supports the sides and underside of the test strip and sample pad) which protrudes inwardly into the channel toward the sample pad to reduce free space of the channel surrounding the sample pad (see fig. 11a).
Regarding claim 3, the rapid test device according to claim 2, wherein an inner top surface of the at least one flow gate borders with a top surface of the sample pad (See fig. 11a, ref. 36a).
Regarding claim 4, the rapid test device according to claim 2, wherein at least one inner side surface of the at least one flow gate borders a corresponding side surface of the sample pad (fig. 11a, ref. 36a and portion 18 in fig. 8 at area which protrudes up and supports the sides and underside of the test strip and sample pad)).
Regarding claim 5, the rapid test device according to claim 2, wherein the at least one flow gate borders the sample pad to be air permeable in the flow direction (this limitation does not further structurally limit the instant claim. The at least one flow gate borders the sample pad, 36a).
Regarding claim 6, the rapid test device according to claim 2, wherein a first flow gate among the at least one flow gate is located at an end of the sample collection cavity opposite to the saliva receiving port (36a).
Regarding claim 7, the rapid test device according to claim 2, comprising a first (36c) and a second flow gate (last gate which claims second end of test strip down stream of window 34)) spaced apart from each other along the flow direction so as to form an overflow cavity (see void between 36c and 36d) between the first and the second flow gate, wherein a venting hole (38) is formed in an upper portion of the overflow cavity between the first and the second flow gate (see fig. 11a).
Regarding claim 8, the rapid test device according to claim 7, wherein an area of the venting hole is larger than an area of the free space of the channel surrounding the sample pad at the first and/or second flow gate (see fig. 11a).
Regarding claim 9, the rapid test device according to claim 7, further comprising a third flow gate (end 18 at as seen in fig. 4) downstream of and spaced apart from the second flow gate.
Regarding claim 10, the rapid test device according to claim 1, wherein the elongate housing comprises an upper flow indication window (window 34) positioned downstream from the at least one flow gate overlapping a conjugate pad of the lateral flow test strip.
Regarding claim 11, the rapid test device according to claim 1, wherein the elongate housing comprises a flat bottom sheet (10) and a thermoformed thermoplastic top sheet (30, thermoplastic, para 78) coupled to the flat bottom sheet to form the elongate housing (see fig. 7-11a).
Regarding claim 12, the rapid test device according to claim 11, wherein the thermoformed thermoplastic top sheet includes at least one of polyactide (PLA), polystyrene (PS) or polyethylene terephthalate (PET), and/or has a thickness in the range of 0.1 to 0.5 mm (para 78).
Regarding claim 13, the rapid test device according to claim 1, wherein the elongate housing is injection molded (this limitation is drawn to a product by process and is not given patentable weight in claims directed to a device).
Regarding claim 14, the rapid test device according to claim 1, wherein a volume of the sample collection cavity is between 150 µl and 400 µl (para 70).
Regarding claim 15, the rapid test device according to claim 1, wherein a width of the saliva receiving port is larger than a height of the saliva receiving port (see fig. 11a).
Regarding claim 16, Kim discloses a rapid test device for detecting a target analyte in a saliva sample, the rapid test device (fig. 8-11b) comprising:
an elongate housing (10/30 lower and upper case) forming an interior channel extending in a flow direction (see fig. 9-11b; the claim does not specifically state the flow direction is parallel to the length of the elongated housing. The flow direction as broadly interpreted can flow up and down and left to right);
a lateral flow test strip (20) for detecting the target analyte being accommodated in the elongate housing and extending along the channel in flow direction, wherein the lateral flow test strip includes a sample pad (21); and wherein the elongate housing includes at least one flow gate (fig. 11a, ref. 36a and portion 18 at area which protrudes up and supports the sides and underside of the test strip and sample pad) that protrudes inwardly into the channel toward the sample pad to reduce free space of the channel surrounding the sample pad (fig. 11a),
wherein an inner top surface (surface of 36a touches the top surface of the sample pad) of the at least one flow gate borders with a top surface of the sample pad, and wherein at least one inner side surface of the at least one flow gate borders a corresponding side surface of the sample pad (36a contacts the sample pad at the top surface and the side surface of the flow gate walls 18 as shown in fig. 8 surround the sidewalls of the sample pad);
a saliva receiving port (32) at an end portion (an end portion is generally interpreted as the left side of the elongated housing) of the elongate housing configured to receive the saliva sample directly from a mouth of a user (this limitation does not further structurally limit the instant claim. Further a saliva sample is not positively recited and therefore is not part of the claim structures); and
a sample collection cavity (14/12) extending from the saliva receiving port in the flow direction for collecting the saliva sample received through the saliva receiving port (the sample is received at saliva receiving port 32 and then to sample collection cavity);
wherein the sample pad (21) of the lateral flow test strip extends into the sample collection cavity to receive saliva collected in the sample collection cavity.
Regarding claim 17, the rapid test device according to claim 16, wherein the at least one flow gate borders the sample pad to be air permeable in the flow direction (this limitation does not further structurally limit the instant claim. The at least one flow gate borders the sample pad, 36a).
Regarding claim 18, the rapid test device according to claim 16, wherein a first flow gate 36a and sidewalls 18) among the at least one flow gate is located at an end of the sample collection cavity (12) opposite to the saliva receiving port (32).
Regarding claim 19, Kim discloses a rapid test device for detecting a target analyte in a saliva sample, the rapid test device (fig. 8-11b) comprising:
an elongate housing (10/30 lower and upper case) forming an interior channel extending in a flow direction (see fig. 9-11b; the claim does not specifically state the flow direction is parallel to the length of the elongated housing. The flow direction as broadly interpreted can flow up and down and left to right);
a lateral flow test strip (20) for detecting the target analyte being accommodated in the elongate housing and extending along the channel in flow direction, wherein the lateral flow test strip includes a sample pad (21); wherein the elongate housing comprises a flat bottom sheet (10) and a thermoformed thermoplastic top sheet (30) coupled to the flat bottom sheet to form the elongate housing (para 78; see fig. 7-11a);
a saliva receiving port (32) at an end portion (an end portion is generally interpreted as the left side of the elongated housing) of the elongate housing configured to receive the saliva sample directly from a mouth of a user (this limitation does not further structurally limit the instant claim. Further a saliva sample is not positively recited and therefore is not part of the claim structures); and
a sample collection cavity (14/12) extending from the saliva receiving port in the flow direction for collecting the saliva sample received through the saliva receiving port (the sample is received at saliva receiving port 32 and then to sample collection cavity);
wherein the sample pad (21) of the lateral flow test strip extends into the sample collection cavity to receive saliva collected in the sample collection cavity.
Regarding claim 20. The rapid test device according to claim 19, wherein the thermoformed thermoplastic top sheet includes at least one of polyactide (PLA), polystyrene (PS) or polyethylene terephthalate (PET), and/or has a thickness in the range of 0.1 to 0.5 mm (para 78).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SAMUEL P SIEFKE whose telephone number is (571)272-1262. The examiner can normally be reached Monday-Friday 8-5.
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/SAMUEL P SIEFKE/Primary Examiner, Art Unit 1758
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