DETAILED ACTION
Notice of AIA Status
The present application, filed on 4/17/2024, is being examined under the first inventor to file provisions of the AIA .
Status of Claims
Claims 1-9 are pending.
Claims 1-9 are objected to.
Claims 1-4 and 8-9 are rejected.
Claim Objections
Claims 1-9 are objected to because of the following informalities:
Claim 1 recites “a paper strip guide including a groove and a paper strip which is formed in the groove and whose color is changed by the urine”. For clarity consider rephrasing to ‘a paper strip guide including a main groove and a paper strip in the main groove and exhibiting a color configured to change upon contact with the urine’.
Claim 1 recites “when a pressure difference is made between the inside and the outside of the air pump”. For clarity consider rephrasing to ‘when the internal pressure of the air pump is different from atmospheric pressure’.
Claim 3 recites “the paper strip is spaced apart by a predetermined distance from a lower end of a lower flow path of the paper strip guide”. For clarity consider rephrasing to ‘the paper strip guide includes a lower flow path including a lower end and the paper strip is spaced apart by a predetermined distance from the lower end’.
Claim 7 recites “wherein a plurality of grooves is formed in a lower portion of the paper strip guide and merged into one groove in an upper portion of the paper strip guide”. For clarity consider rephrasing to ‘wherein the paper strip guide includes an upper portion, a lower portion and a plurality of secondary grooves in the lower portion, and wherein the upper portion includes the main groove and the plurality of secondary grooves merges into the main groove’.
Claim 8 recites “a sheet which is attached to one surface of the container and in which a liquid specimen flow path is formed and at least one paper strip whose color is changed by the liquid specimen is provided in at least a part of the flow path”. For clarity consider rephrasing to ‘a sheet attached to one surface of the container and defining a flow path for the liquid specimen;
at least one paper strip disposed along at least a portion of the flow path and exhibiting a color configured to change upon contact with the liquid specimen’.
Claim 9 recites “wherein when the pressing member is compressed, air inside the pressing member is discharged to the outside, and when the pressing member is decompressed, the liquid specimen flows to the paper strip through the flow path due to a pressure difference between the inside and the outside of the pressing member”. For clarity consider rephrasing to ‘the pressing member is configured to discharge air outside the pressing member when the pressing member is compressed and to enable the liquid specimen to flow to the paper strip through the flow path when the pressing member is decompressed due to the internal pressure of the pressing member being different from atmospheric pressure’.
Claims dependent on an objected base claim are also objected to because any claim in dependent form is construed to incorporate by reference all the limitations of the claim to which it refers.
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.
Claims 1-4 and 8-9 are rejected under 35 U.S.C. 103 as being unpatentable over Vallejo (US20090181471, cited in the Information Disclosure Statement (IDS) dated 4/17/2024) in view of Shim (KR 2015-0136631 A, mapped to the English translation).
With respect to claim 1, Vallejo (US20090181471) teaches a urine test kit (assay device 10 in [0024]), comprising:
a container (cup-like transparent test container 10 in [0024]) configured to contain urine (urine sample in [0007], which recites “a urine sample retained in the container”);
a paper strip guide (flexible transparent cover sheet 22 in [0027]) including a groove (one of the parallel elongated pockets 23 in [0027]) and a paper strip (immunoassay test strip 24 in [0027]) which is formed in the groove (the one of the parallel elongated pockets 23) and whose color is changed by the urine (urine sample) (the color of the immunoassay test strip 24 changes in response to the urine sample, see [0034]-[0035]); and
wherein the paper strip guide (flexible transparent cover sheet 22) is attached to one surface of the container (cup-like transparent test container 10) to form a flow path between the groove (the one of the parallel elongated pockets 23) in the paper strip guide (flexible transparent cover sheet 22) and the one surface of the container (cup-like transparent test container 10) (see Fig. 1).
Vallejo fails to teach an air pump configured to enable the urine to flow to the paper strip.
In the analogous art of analytical devices, Shim (KR 2015-0136631 A) teaches an air pump (pumping part 130 on page 3) configured to enable the urine to flow to the paper strip (see page 4, which recites “the channel part 110 has a moving path 112 capable of moving urine which is an inflow fluid and the moving path 112 is connected to an inlet port 111 and an air port 113, 111 communicate with the pumping part 130 so that the urine flows from the inlet port 111 in accordance with the pressure change of the pumping part 130… The fluid flowing into the inflow port 111 (urine) flows through the transfer passage 112 and flows into the inflow port 111 through the urine located in the transfer passage 112 So that the inspection sheet 120 can be wetted”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the urine test kit as disclosed by Vallejo by incorporating the air pump as disclosed by Shim with a reasonable expectation of success for the benefit of enabling the urine to flow and wet the paper strip (inspection sheet 120 in Shim) (see page 4 of Shim, which recites “The air inlet 113 may allow air to flow in so that the urine can flow more easily when the urine flows in through the inlet. When the pumping unit 130 is present, the air inlet 113 is connected to the pumping unit 130, so that the air is moved by the positive pressure or the negative pressure of the pumping unit 130. That is, the air in the pumping space 131 enters the air inlet 113 by pressing the pumping part 130, and when the force pressed by the pumping part 130 is removed, To the pumping space (131)…. The pumping unit 130 has a pumping space 131 formed therein and communicates with the air inlet 113 to generate a negative pressure in
the moving passage 112 so as to cause a volume change in the pumping space 131 So that the urine can flow into the moving passage 112 from the inlet 111”).
With respect to claim 2, Vallejo in view of Shim teaches the urine test kit of claim 1,
wherein the air pump (pumping part 130) is configured to enable the urine to flow to the paper strip (inspection sheet 120) through the flow path (moving path 112) when a pressure difference is made between the inside and the outside of the air pump (pumping part 130) through a pumping operation by compressing and decompressing the air pump (pumping part 130). Shim teaches a pumping part 130 formed of an elastic material configured to compress and decompress such that the compression and decompression of the pumping part 130 changes the volume and pressure of the pumping space, thereby generating a pressure difference enabling the urine to flow through moving path 112 to inspection sheet 120 (see page 4 of Shim, which recites “The air inlet 113 may allow air to flow in so that the urine can flow more easily when the urine flows in through the inlet. When the pumping unit 130 is present, the air inlet 113 is connected to the pumping unit 130, so that the air is moved by the positive pressure or the negative pressure of the pumping unit 130. That is, the air in the pumping space 131 enters the air inlet 113 by pressing the pumping part 130, and when the force pressed by the pumping part 130 is removed, To the pumping space (131)…. The pumping unit 130 has a pumping space 131 formed therein and communicates with the air inlet 113 to generate a negative pressure in the moving passage 112 so as to cause a volume change in the pumping space 131 So that the urine can flow into the moving passage 112 from the inlet 111”).
With respect to claim 3, Vallejo in view of Shim teaches the urine test kit of claim 1,
wherein the paper strip (immunoassay test strip 24) is spaced apart by a predetermined distance from a lower end (bottom end 27 in [0027], which recites “the pockets 23 are positioned such that they extend longitudinally or vertically within the container when the assay assembly is mounted within the container as seen in FIG. 1. Each pocket 23 has its top 25 and longitudinal sides 26 closed or sealed against the body portion of the cover sheet, but the bottom ends 27 of the pockets are open”) of a lower flow path (pocket 23) of the paper strip guide (flexible transparent cover sheet 22) (see Fig. 2 of Vallejo, which illustrates the paper strip (immunoassay strip 24) is spaced from the lower end 27 of pocket 23).
With respect to claim 4, Vallejo in view of Shim teaches the urine test kit of claim 1,
wherein the paper strip guide is spaced apart by a predetermined distance from a lower portion of the container (cup-like transparent test container 10) (see Fig. 2 of Vallejo) and attached along an inner circumferential surface of the container (cup-like transparent test container 10) (see Fig. 2 of Vallejo).
With respect to claim 8, Vallejo (US20090181471) teaches a urine test kit (assay device 10 in [0024]), comprising:
a container (cup-like transparent test container 10 in [0024]) configured to contain a liquid specimen (urine sample in [0007], which recites “a urine sample retained in the container”);
a sheet (flexible transparent cover sheet 22 in [0027]) which is attached to one surface of the container (cup-like transparent test container 10) and in which a liquid specimen flow path (one pocket of the parallel elongated pockets 23 in [0027]) is formed and at least one paper strip (immunoassay test strip 24 in [0027]) whose color is changed by the liquid specimen is provided in at least a part of the flow path (the one pocket of the parallel elongated pockets 23) (the color of the immunoassay test strip 24 changes in response to the liquid specimen, see [0034]-[0035]).
Vallejo fails to teach a pressing member configured to enable the liquid specimen to flow to the paper strip.
In the analogous art of analytical devices, Shim (KR 2015-0136631 A) teaches an air pump (pumping part 130 on page 3) configured to enable the urine to flow to the paper strip (see page 4, which recites “the channel part 110 has a moving path 112 capable of moving urine which is an inflow fluid and the moving path 112 is connected to an inlet port 111 and an air port 113, 111 communicate with the pumping part 130 so that the urine flows from the inlet port 111 in accordance with the pressure change of the pumping part 130… The fluid flowing into the inflow port 111 (urine) flows through the transfer passage 112 and flows into the inflow port 111 through the urine located in the transfer passage 112 So that the inspection sheet 120 can be wetted”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the urine test kit as disclosed by Vallejo by incorporating the air pump as disclosed by Shim with a reasonable expectation of success for the benefit of enabling the urine to flow and wet the paper strip (inspection sheet 120 in Shim) (see page 4 of Shim, which recites “The air inlet 113 may allow air to flow in so that the urine can flow more easily when the urine flows in through the inlet. When the pumping unit 130 is present, the air inlet 113 is connected to the pumping unit 130, so that the air is moved by the positive pressure or the negative pressure of the pumping unit 130. That is, the air in the pumping space 131 enters the air inlet 113 by pressing the pumping part 130, and when the force pressed by the pumping part 130 is removed, To the pumping space (131)…. The pumping unit 130 has a pumping space 131 formed therein and communicates with the air inlet 113 to generate a negative pressure in
the moving passage 112 so as to cause a volume change in the pumping space 131 So that the urine can flow into the moving passage 112 from the inlet 111”).
With respect to claim 9, Vallejo in view of Shim teaches the urine test kit of claim 8,
wherein when the pressing member (pumping part 130) is compressed, air inside the pressing member (pumping part 130) is discharged to the outside, and when the pressing member is decompressed (pumping part 130), the liquid specimen (urine sample) flows to the paper strip (immunoassay test strip 24) through the flow path (moving path 112) due to a pressure difference between the inside and the outside of the pressing member (pumping part 130). Shim teaches a pumping part 130 formed of an elastic material configured to compress and decompress such that the compression and decompression of the pumping part 130 changes the volume and pressure of the pumping space, thereby generating a pressure difference enabling the urine to flow through moving path 112 to inspection sheet 120 (see page 4 of Shim, which recites “The air inlet 113 may allow air to flow in so that the urine can flow more easily when the urine flows in through the inlet. When the pumping unit 130 is present, the air inlet 113 is connected to the pumping unit 130, so that the air is moved by the positive pressure or the negative pressure of the pumping unit 130. That is, the air in the pumping space 131 enters the air inlet 113 by pressing the pumping part 130, and when the force pressed by the pumping part 130 is removed, To the pumping space (131)…. The pumping unit 130 has a pumping space 131 formed therein and communicates with the air inlet 113 to generate a negative pressure in the moving passage 112 so as to cause a volume change in the pumping space 131 So that the urine can flow into the moving passage 112 from the inlet 111”).
Allowable Subject Matter
Claims 5-7 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
With respect to claim 5, Vallejo in view of Shim teaches the urine test kit of claim 1, further comprising:
a lid (cap 16 in [0025] of Vallejo) configured to seal an upper portion of the container (cup-like transparent test container 10) (see Fig. 2 of Vallejo). In addition, in Shim the pump 130 is directly interfaced with air port 113 of channel 110 and is disposed over the port rather than being connected through a lid by a hose.
Vallejo in view of Shim fails to teach or reasonably suggest that the lid includes a lid connection hole in its upper surface, and a connection hose which connects the air pump and the paper strip guide passes through the lid connection hole.
With respect to claim 6, Vallejo in view of Shim teaches the urine test kit of claim 1. In Shim the pump 130 is directly interfaced with air port 113 of channel 110 and is disposed over the port rather than being connected through a side surface of the container by a hose.
Vallejo in view of Shim fails to teach or reasonably suggest that a container connection hole is formed in a side surface of the container, and a connection hose which connects the air pump and the paper strip guide passes through the container connection hole.
With respect to claim 7, Vallejo in view of Shim teaches the urine test kit of claim 1,
Vallejo in view of Shim fails to teach or reasonably suggest that a plurality of grooves is formed in a lower portion of the paper strip guide and merged into one groove in an upper portion of the paper strip guide.
Conclusion
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/JONATHAN BORTOLI/Examiner, Art Unit 1797
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