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 .
Election/Restrictions
Applicant’s election without traverse of group I, claims 1-7, in the reply filed on 03/30/2026 is acknowledged.
Claim 8 is withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 03/30/2026.
Status of Claims
Claims 1-8 remain pending in the application, with claims 1-7 being examined and claim 8 being withdrawn pursuant to the election filed 03/30/2026.
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.
Claim(s) 1-7 is/are rejected under 35 U.S.C. 103 as being unpatentable over translated 이창수 (KR-101493051-B1) (translated to be Changsoo Lee, and herein will be referred to as Lee) in view of Benco (US-2017/0043341-A1).
Regarding claim 1, Lee teaches a sheet-shaped testing chip (Figure 8 showing a 3D μPAD), comprising:
a first layer (upper-section) on one surface side and a second layer (lower-section) on another surface side (please see Figure 8), wherein
the first layer (upper-section) and second layer (lower-section) are adjacent ([0058] describes Figure 6 where a wax pattern was printed through double-sided printing to the patterns faced the front and back sides of the paper, where Figure 7 shows the pattern of Figure 6 where the three-dimensional flow path is capable of vertical and horizontal movement formed in one sheet of paper. Figure 8 is understood to be formed similarly, and thus the upper-section and lower-section will be adjacent to each other),
either the first layer (upper-section) has a liquid-receiving section A (see annotated Figure 8 below, where it shows the 3D view when both the upper-section and lower-section are together),
the first layer (upper-section) has at least a detection-confirming section B (see annotated Figure 8 below),
the second layer (lower-section) has at least a liquid-distributing section D adjacent to the detection-confirming section B and a liquid flow path E connected to the liquid-distributing section D (see annotated Figure 8 below. Similar to Figure 6, the pattern that forms the upper-section will define the liquid-receiving section A and the detection-confirming section B, where the pattern that forms the lower-section will define the liquid flow path E and liquid distributing section D),
in a case where the first layer has the liquid-receiving section A, the liquid-receiving section A is separate from the detection-confirming section B (see annotated Figure 8 below),
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the first layer (upper-section) is formed on one side of a sheet of sheet-shaped material, and the second layer (lower-section) is formed on the other side of the sheet-shaped material ([0058] see three-dimensional flow path capable of vertical and horizontal movement of fluid is formed in one sheet of paper, see Figure 8 which is formed the same way as described for Figure 6),
the liquid-receiving section A, the liquid flow path E, the liquid-distributing section D, and the detection-confirming section B are made of a material M in which distribution of a test liquid is expressed by capillary action ([0061] see pattern printed on opposite sides of the paper),
parts other than parts made of the material M are made of a material in which distribution of the test liquid is not expressed ([0058] see wax pattern), and
the testing chip (Figure 8) is configured such that when the test liquid is dropped onto the liquid-receiving section A, the test liquid distributes through the liquid-receiving section A, the liquid flow path E, and the liquid-distributing section D in this order by capillary action to reach the detection-confirming section B (please see Figure 9 which shows a solution flowing through the device), and
However, Lee does not teach wherein among surfaces of the first layer and surfaces of the second layer, at least surfaces of the material M other than the liquid-receiving section A are sealed with a film, thereby controlling the amount of the test liquid reaching the detection-confirming section B.
In the analogous art of microfluidic devices, Benco teaches a substrate with at least one reaction channel in a pattern (Benco; [0012], [0013]).
Specifically, Benco teaches where a substrate 12 has the at least one reaction channel 14 defined by a barrier material 16 (Benco; [0013], Figure 1). The substrate 12 seen in Figure 3 is sandwiched between a first backing and a second backing 20A and 20B to protect the substrate 12 from environmental conditions and maintain the integrity of the test enabled by reagent 18 (Benco; [0015]). As described in [0016] of Benco, either the first backing 20A or second backing 20B may comprise one or more first apertures 24 that serve as a respective sample port 26 for receiving a sample to be distributed to the reaction channels.
It would have been obvious to one skilled in the art to modify the 3D μPAD of Lee such that it is sandwiched between a first and second backing, where there is an opening where the liquid receiving section A is located (please see annotated Figure 8 supra) as taught by Benco because Benco teaches that the backings protect the substrate from environmental conditions and maintain the integrity of the test (Benco; [0015]).
The limitations “the testing chip is configured such that when the test liquid is dropped onto the liquid-receiving section A, the test liquid distributes through the liquid-receiving section A, the liquid flow path E, and the liquid-distributing section D in this order by capillary action to reach the detection-confirming section B” and “controlling the amount of the test liquid reaching the detection-confirming section B” are directed to the function of the apparatus and/or the manner of operating the apparatus, and all the structural limitations of the claim has been disclosed by modified Lee, and test liquid is capable of being dropped onto liquid-receiving section A and then distributing through liquid flow path E, liquid-distributing section D, and then reaching detection-confirmation section B. Further the backings of Benco with the aperture at the sample port is capable of controlling the amount of test liquid that reaches the detection-confirming section B. As such, it is deemed that the claimed apparatus is not differentiated from the apparatus of modified Lee (see MPEP §2114).
Further, please note that the test liquid has not been positively recited in the claim, and is therefore not a part of the claimed testing chip.
Regarding claim 2, modified Lee teaches the testing chip according to claim 1. Lee further teaches wherein
the first layer (upper-section) has the liquid-receiving section A separate from the detection-confirming section B (please see annotated Figure 8 supra),
the second layer (lower-section) has a liquid-distributing section C made of the material M, adjacent to the liquid receiving section A, and connected to the liquid flow path E (please see annotated Figure 8 below, where the liquid-distributing section C is formed by the pattern that forms the lower-section and is directly below the liquid receiving section A formed by the upper-section pattern), and
the testing chip (Figure 8) is configured such that when the test liquid is dropped onto the liquid-receiving section A, the test liquid distributes through the liquid-receiving section A, the liquid-distributing section C, the liquid flow path E and the liquid-distributing section D in this order by capillary action to reach the detection-confirming section B (please see Figure 8 below as well as Figure 9 which shows the progression of a solution through the device of Lee).
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The limitation “the testing chip is configured such that when the test liquid is dropped onto the liquid-receiving section A, the test liquid distributes through the liquid-receiving section A, the liquid-distributing section C, the liquid flow path E and the liquid-distributing section D in this order by capillary action to reach the detection-confirming section B” is directed to the function of the apparatus and/or the manner of operating the apparatus, and all the structural limitations of the claim has been disclosed by modified Lee, and test liquid is capable of being dropped onto liquid-receiving section A and then distributing through liquid-distributing section C, liquid flow path E, liquid-distributing section D, and then reaching detection-confirmation section B. As such, it is deemed that the claimed apparatus is not differentiated from the apparatus of modified Lee (see MPEP §2114).
Further, please note that the test liquid has not been positively recited in the claim, and is therefore not a part of the claimed testing chip.
Regarding claim 3, modified Lee teaches the testing chip according to claim 1. Lee further teaches wherein the material M is filter paper (Lee; [0038] describes where the paper used is Whatman 3MM chromatography paper, which is understood to be a specific type of filter paper).
Regarding claim 4, modified Lee teaches the testing chip according to claim 1. Lee further teaches wherein the material in which distribution of the test liquid is not expressed is a material Mʹ obtained by impregnating the material M with a hydrophobic material (Lee; [0058] see wax pattern is printed and then subjected to heat treatment that is understood to impregnate the paper with the wax. Additionally, Figure 7 shows a cross-sectional view of the microfluidic device from Figure 6, where the wax is seen to be impregnated into the paper).
Regarding claim 5, modified Lee teaches the testing chip according to claim 4.
The limitations of claim 5 are directed to the function of the apparatus and/or the manner of operating the apparatus, and all the structural limitations of the claim has been disclosed by modified Lee, and the wax of Lee is capable having a gastight degree of 15 seconds or less. As such, it is deemed that the claimed apparatus is not differentiated from the apparatus of modified Lee (see MPEP §2114).
Further, while modified Lee does not address gastight degree, it has been determined that where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In the current case, obviousness. Absent persuasive evidence that the wax and chromatography paper are different, the prior art is considered to have the same properties with respect to gastight degree as that is claimed. MPEP § 2112.01 (I-IV).
Regarding claim 6, modified Lee teaches the testing chip according to claim 4.
The limitations of claim 6 are directed to the function of the apparatus and/or the manner of operating the apparatus, and all the structural limitations of the claim has been disclosed by modified Lee, and the wax of Lee is capable of having an impregnation ratio in which the material M is impregnated with the hydrophobic material to obtain the material Mʹ is 70% or less. As such, it is deemed that the claimed apparatus is not differentiated from the apparatus of modified Lee (see MPEP §2114).
Further, while modified Lee does not address the impregnation ratio, it has been determined that where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In the current case, obviousness. Absent persuasive evidence that the wax and chromatography paper are different, the prior art is considered to have the same properties with respect to impregnation ratio as that is claimed. MPEP § 2112.01 (I-IV).
Regarding claim 7, modified Lee teaches the testing chip according to claim 1. Lee further teaches wherein a coloring reaction caused by a substance to be detected occurs in the detection-confirming section B (Lee; [0064] describes Figure 9C whereas the concentration of BSA increased the color changed to blue in a larger number of detection areas, where the first detection area on the left is the detection-confirming section B as described supra).
Claim(s) 3 is/are alternatively rejected under 35 U.S.C. 103 as being unpatentable over translated 이창수 (KR-101493051-B1) (translated to be Changsoo Lee, and herein will be referred to as Lee) and Benco (US-2017/0043341-A1), and in further view of Zhou (US-2015/0367341-A1).
Regarding claim 3, modified Lee teaches the testing chip according to claim 1. If it is determined that the chromatography paper of Lee is not a specific type of filter paper, in the analogous art of depositing wax on paper to create chemical assay devices, Zhou teaches that the paper may be a filter paper or chromatography paper (Zhou; [0020], [0021], [0029]).
Examiner further finds that the prior art contained a device/method/product (i.e., 3D μPAD) which differed from the claimed device by the substitution of component(s) (i.e., paper being chromatography paper) with other component(s) (i.e., the paper being filter paper), and the substituted components and their functions were known in the art as above set forth. An ordinarily skilled artisan could have substituted one known element with another (i.e., chromatography paper for filter paper), and the results of the substitution (i.e., impregnation of wax and fluid flow of a liquid) would have been predictable.
Therefore, pursuant to MPEP §2143 (I), Examiner concludes that it would have been obvious to an ordinarily skilled artisan to substitute the chromatography paper of reference Lee with filter paper of reference Zhou, since the result would have been predictable.
Other References Cited
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Eason (US-2019/0168217-A1) teaches a 3D device formed in a single paper substrate, where Figure 12 shows an enclosed flow-bath formed by creating polymerized blocks from both faces of a single paper substrate (Eason; [0164], [0165]).
Vella (US-2016/0207038-A1) teaches where the pattern of hydrophobic material on either side of a substrate may be the same pattern or different patterns (Vella; [0028]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SOPHIA LYLE whose telephone number is (571)272-9856. The examiner can normally be reached 8:30-5:00 M-Th.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Curtis Mayes can be reached at (571)272-1234. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/S.Y.L./Examiner, Art Unit 1796
/MELVIN C. MAYES/Supervisory Patent Examiner, Art Unit 1759
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