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 .
Response to Amendment
Applicant’s amendment filed on 04/15/26 has been entered. Claims 12-20 has been cancelled. The Restriction Requirement mailed on 02/19/26 is moot in light of Applicant’s cancellation.
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(s) 1, 2, 6, 7, and 9-10 is/are rejected under 35 U.S.C. 102(a)(1) as anticipated by Lee (TWM422956U)
Regarding claim 1, Lee discloses a housing (Main body 101, Fig. 1) for a lateral flow assay device assay system (Fig. 1):
a first portion (Bottom layer Main body 101, Fig. 1) including an opening (biochemical detector holes 19, Fig. 7);
a second portion (Top layer Main body 101, Fig. 1) coupled to the first portion and house a lateral flow assay strip (test piece 102, Fig. 6-7), the second portion including a first clip (pressing arm 17, Fig. 6-7);
a push button (button 16, Fig. 6-7) moveable from a first position (Fig. 6) to a second position (Fig. 7) between the first portion and the second portion, the push button including a second clip (pushing piece 11, Fig. 6-7) to engage the first clip (Fig. 7) of the second portion to maintain the push button in the second position when moved into the second position; and
Regarding claims 2, 6, and 7, Lee discloses the claimed invention as discussed above in claim 1. The limitations of the push button causing electrodes (claim 2) or a printed circuit board layer (claims 6-7) into contact the lateral flow assay strip are recitation of intended use as the printed circuit board layer and electrodes are not recited as part of the housing, but rather as an article in which the apparatus acts upon. Manner of operating an apparatus does not differentiate apparatus claim from the prior art. A claim containing a “recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus” if the prior art apparatus teaches all the structural limitations of the claim (MPEP 2114, II). A recitation of 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. Moreover, Lee discloses the push button is to press a printed circuit board layer (circuit board 103, Fig. 1-4 and 6-7) in contact with the lateral flow assay strip (Upon insertion of the test strip, the second end of the pressure arm presses against the test strip, thereby establishing a stable signal connection between the test strip and the corresponding terminals situated on the circuit board within the biochemical detection device. page 6, para. 1).
Regarding claims 9-10, Lee discloses an assay system (Fig. 1):
a first portion (Bottom layer Main body 101, Fig. 1);
a second portion (Top layer Main body 101, Fig. 1) coupled to the first portion, the second portion including a first clip (pressing arm 17, Fig. 6-7); a lateral flow assay strip (test piece 102, Fig. 6-7) between the first portion and the second portion;
a push button (trip button 16, Fig. 6-7) moveable from a first position (Fig. 6) to a second position (Fig. 7) between the first portion and the second portion, the push button including a second clip (pushing piece 11, Fig. 6-7) to engage the first clip (Fig. 7) of the second portion to maintain the push button in the second position when moved into the second position; and
a printed circuit board layer (circuit board 103, Fig. 1-4 and 6-7), wherein the push button is to press the printed circuit board layer into contact with the lateral flow assay strip when the push button is in the second position (Upon insertion of the test strip, the second end of the pressure arm presses against the test strip, thereby establishing a stable signal connection between the test strip and the corresponding terminals situated on the circuit board within the biochemical detection device. page 6, para. 1).
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1-9 and 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Smart (US 20150044098 A1) in view of Salari (US 20210187198 A1).
Regarding claim 1, Smart discloses a housing (Housing 70, Fig. 7) for a lateral flow assay device (test strips 74, Fig. 7) comprising:
a first portion including an opening (window 90, Fig. 9); though not explicitly stated, the opening is interpreted to be implicitly present for holding the button 88, Fig. 9);
a second portion (see annotated Fig. 9 below) coupled to the first portion and house a lateral flow assay strip (end 86 of a test strip, Fig. 9)
a push button located within the opening of the first portion, the push button moveable from a first position to a second position (button 88, Fig. 9).
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Smart does not explicitly disclose the second portion including a first clip, and the push button including a second clip to engage the first clip of the second position to maintain the push button in the second position when moved into the second position.
However, Smart discloses button used in the embodiment can be on/off button (An on/off button 124 is located on the bottom of the device, and the battery 108 inside of the casing is connected to on/off button 124. Para. [0137]), which is a latching mechanism that stays in the position one pushes it into until one presses it again.
Analogous and evidential reference Salari discloses an on/off push button for an injection system, the push button assembly comprises:
push button (push button 26, Fig. 2; para. [0046])),
a second portion (interior of injector 10 of Fig. 2) including a first clip (top retainer 28, Fig. 2; para. [0046]), and
the push button including a second clip (spring clip 27, Fig. 2) to engage the first clip of the second position to maintain the push button in the second position when moved into the second position (Fig. 2).
As Smart already discloses the applicability of on/off button in the device, it would have been obvious to one of ordinary skill in the art before the effective filing date to have modified the push button and the housing of smart by incorporating two clips, one in the push button and one in the interior of housing holding the test strip, based on teaching such as the one taught in Salari, to derive the claimed invention. Doing so avoids the need for an operator to continuously pressing the button to contact the test strip into the mixed reagents (Fig. 9; para. [0124], Smart).
Regarding claims 2, 6, and 7, Modified Smart discloses the claimed invention as discussed above in claim 1. The limitations of the push button causing electrodes (claim 2) or a printed circuit board layer (claims 6-7) into contact the lateral flow assay strip are recitation of intended use as the printed circuit board layer and electrodes are not recited as part of the housing, but rather as an article in which the apparatus acts upon. Manner of operating an apparatus does not differentiate apparatus claim from the prior art. A claim containing a “recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus” if the prior art apparatus teaches all the structural limitations of the claim (MPEP 2114, II). A recitation of 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. Moreover, Smart discloses the push button is configured to causes the test strip to be in contact when pushed and engaged from a first position to a second position (para. [0124; Fig. 9].
Regarding claim 3, Modified Smart discloses the push button includes a blade (the rectangular-shaped button is interpreted as a blade) to cause compression of the lateral flow assay strip when the push button moves to the second position (Fig. 9).
Regarding claim 4, Modified Smart discloses the claimed invention as discussed above in claim 1. Salari, after incorporation into Smart, discloses the push button includes a guide ring (restrain protrusion 26c, Fig. 3A); and
the first portion includes a guidepost (front sliding guide 26 A, Fig. 3A) to engage the guide ring.
Regarding claim 5, Modified Smart discloses the claimed invention as discussed above in claim 1. Salari, after incorporation into Smart, discloses the second portion includes a rib (end fixture 27A, Fig. 3A).
Regarding claim 8, Modified Smart discloses the claimed invention as discussed above in claim 1. Smart discloses the push button includes a rounded top surface (button 88, Fig. 9).
Regarding claim 9, Smart discloses an assay device (Testing device 62, Fig. 7) for a lateral flow assay device (test strips 74, Fig. 7) comprising:
a first portion (window 90, Fig. 9);
a second portion (see annotated Fig. 9 below) coupled to the first portion, a lateral flow assay strip between the first and second portion (end 86 of a test strip, Fig. 9)
a push button located within the opening of the first portion, the push button moveable from a first position to a second position (button 88, Fig. 9).
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Smart does not explicitly disclose the second portion including a first clip, and the push button including a second clip to engage the first clip of the second position to maintain the push button in the second position when moved into the second position.
However, Smart discloses button used in the embodiment can be on/off button (An on/off button 124 is located on the bottom of the device, and the battery 108 inside of the casing is connected to on/off button 124. Para. [0137]), which is a latching mechanism that stays in the position one pushes it into until one presses it again.
Analogous and evidential reference Salari discloses an on/off push button for an injection system, the push button assembly comprises:
push button (push button 26, Fig. 2; para. [0046])),
a second portion (interior of injector 10 of Fig. 2) including a first clip (top retainer 28, Fig. 2; para. [0046]), and
the push button including a second clip (spring clip 27, Fig. 2) to engage the first clip of the second position to maintain the push button in the second position when moved into the second position (Fig. 2).
As Smart already discloses the applicability of on/off button in the device, it would have been obvious to one of ordinary skill in the art before the effective filing date to have modified the push button and the housing of smart by incorporating two clips, one in the push button and one in the interior of housing holding the test strip, based on teaching such as the one taught in Salari, to derive the claimed invention. Doing so avoids the need for an operator to continuously pressing the button to contact the test strip into the mixed reagents (Fig. 9; para. [0124], Smart).
Regarding claim 11, Modified Smart discloses the claimed invention as discussed above in claim 9. Salari, after incorporation into Smart, discloses the push button includes a guide ring (restrain protrusion 26c, Fig. 3A); and
One of the first or the second portion includes a guidepost (front sliding guide 26 A, Fig. 3A), the guide ring slidable along the guidepost to prevent tilting of the push button as the push button moves between the first position and the second position (push button 26 with front sliding guide 26A and rear sliding guide 26B and restrainer protrusion 26C and lever contact 26D, button position restoring clip spring 27 with end fixture 27A and sliding tip 27B, para. [0046]).
Claim(s) 9-10 is/are rejected under 35 U.S.C. 102(a)(1) as anticipated by Lee (TWM422956U)
Regarding claims 9-10, Lee discloses an assay system (Fig. 1):
a first portion (Top layer Main body 101, Fig. 1);
a second portion (Bottom layer Main body 101, Fig. 1) coupled to the first portion, the second portion including a first clip (pressing arm 17, Fig. 6-7); a lateral flow assay strip (test piece 102, Fig. 6-7) between the first portion and the second portion;
a push button (trip button 172, Fig. 6-7) moveable from a first position (Fig. 6) to a second position (Fig. 7) between the first portion and the second portion, the push button including a second clip (pushing piece 11, Fig. 6-7) to engage the first clip (Fig. 7) of the second portion to maintain the push button in the second position when moved into the second position; and
a printed circuit board layer (circuit board 103, Fig. 1-4 and 6-7), wherein the push button is to press the printed circuit board layer into contact with the lateral flow assay strip when the push button is in the second position (Upon insertion of the test strip, the second end of the pressure arm presses against the test strip, thereby establishing a stable signal connection between the test strip and the corresponding terminals situated on the circuit board within the biochemical detection device. page 6, para. 1).
Conclusion
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/M.H./Examiner, Art Unit 1758
/MARIS R KESSEL/Supervisory Patent Examiner, Art Unit 1758
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