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
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.
Claim(s) 1-18 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Tyrrell (US 2015/0056687).
Tyrrell teaches a lateral flow device comprising a first reaction piece, comprising a first substrate; a first separator, located on the first substrate and having a first flow channel exposing at least a portion of the first substrate; and a first cover, covering the first separator and having a first hole in connection with the first flow channel, wherein the first reaction piece has a perforated structure penetrating the first cover, the first separator and the first substrate, and the perforated structure is separated from the first flow channel and the first hole, wherein the first reaction piece has a first viewing zone configured for viewing a portion of the first flow channel via the first cover or the first hole; and a second reaction piece, disposed in adjacent to one side of the first reaction piece of the first substrate and comprising a second substrate; a second separator, located on the second substrate and having a second flow channel exposing at least a portion of the second substrate; and a second cover, covering the second separator and joined to the first substrate, and having a second hole, wherein the second flow channel is in connection with the perforated structure via the second hole, wherein the second reaction piece has a second viewing zone configured for viewing a portion of the second flow channel via the second cover or the second hole. (Refer to Figure 4)
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Regarding claim 2, a spacing distance is between the first viewing zone and the second viewing zone in a longitudinal direction. (Refer to the above figure)
Regarding claim 3, the perforated structure (70a) exposes at least a portion of the second cover (56c).
Regarding claim 4, a width of the perforated structure (70a) is greater than a width of the first hole. (Refer to figure above)
Regarding claim 5, a length of the second flow channel (52h) differs from a length of the first flow channel. (Refer to figure above)
Regarding claim 5, a length of the second flow channel (52h) is greater than a length of the first flow channel. (paragraph [0107])
Regarding claim 7, an adhesive layer disposed between the first substrate and the second cover, wherein the perforated structure penetrates through the adhesive layer. (paragraph [0107])
Regarding claim 8, Applicants further recite “the first flow channel and the second flow channel are not communicable with each other.” This limitation is considered a process and/or intended use limitation, which does not further delineate the structure of the claimed apparatus (i.e. from apparatus claim 1) from that of the prior art. Since claim 1, etc. are drawn to an apparatus statutory class of invention, it is the structural limitations of the apparatus, as recited in the claims, which are considered in determining the patentability of the apparatus itself. This recited process or intended use limitation is accorded no patentable weight to an apparatus. Process limitations are not germane to patentablility to a structure, which is not distinguished from the prior art. A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim.
Regarding claim 9, a first reaction piece, comprising a first substrate, having a first surface and a second surface opposite to the first surface; a first separator, located on the first surface and having a first flow channel; and a first cover, covering the first separator and having a first hole in connection with the first flow channel, wherein the first reaction piece has a perforated structure penetrating the first cover, the first separator and the first substrate; and a second reaction piece, comprising a second substrate, having a third surface and a fourth surface opposite to the third surface, wherein the third surface faces the second surface; a second separator, located on the fourth surface and having a second flow channel; and a second cover, covering the second separator and having second hole, wherein the second hole is in connection with the second flow channel. (Refer to figure above)
Regarding claim 10, an adhesive layer disposed between the second surface and the third surface and joining the first reaction piece and the second reaction piece. (paragraph [0107])
Regarding claim 11, the second reaction piece is aligned with the first reaction piece. (Refer to figure above)
Regarding claim 12, a sampling port (70b) of the second flow channel (52h) is vertically aligned with a sampling port (70b) of the first flow channel (60b).
Regarding claim 13, at least a portion of the second flow channel (52h) overlaps the second hole within the perforated structure. (Refer to figure above)
Regarding claim 14, at least a portion of the second separator overlaps the perforated structure. (Refer to figure above)
Regarding claim 15, a first reaction piece, which comprises a first substrate, having a first surface and a second surface opposite to the first surface; a first separator, located on the first surface and having a first flow channel exposing a first portion of the first substrate; and a first cover, covering the first separator and having a first hole in connection with the first flow channel; forming a perforated structure penetrating the first cover, the first separator and the first substrate; aligning a second sampling port of a second reaction piece with a first sampling port of the first reaction piece, wherein the second reaction piece comprises a second substrate; a second separator, located on the second substrate and having a second flow channel exposing a second portion of the second substrate; a second cover, having a third surface covering the second separator and a fourth surface opposite to the third surface, and having a second hole in connection with the second flow channel, wherein the second flow channel is in connection with the perforated structure via the second hole; and attaching the second reaction piece to the first reaction piece. (Refer to figure above)
Regarding claim 16, before the forming of the perforated structure, further comprising disposing an adhesive layer on the second surface, wherein the perforated structure penetrates through the adhesive layer. (paragraph [107])
Regarding claim 17, after the forming of the perforated structure, further comprising disposing an adhesive layer on the second surface, and the second reaction piece is attached to the first reaction piece via the adhesive layer. (paragraph [107])
Regarding claim 18, the forming of the perforated structure comprises punching, laser engraving, hole-pressing or tumbling. (paragraph [0075])
Conclusion
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/JYOTI Mutreja/ Primary Examiner, Art Unit 1798
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