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 .
Response to Amendments
The claims filed 07/10/2026 are being examined herein
Status of Claims
Claims 1-8, 10-15 remain pending in the application, with claims 1, 6-8 and 10-13 being examined and claims 2-5, 14-15 being withdrawn pursuant to the election filed 08/01/2025.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 11 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 11 recites “wherein the material M’ has an impregnation rate of the hydrophobic material into the material M of 14% or more and 32% or less.” where it is unclear what it is meant by “impregnation rate”. This is because a “rate” is commonly understood to be describing how one quantity changes in relation to another, such as distance over time.
Please see MPEP 2111.01 IV where the applicant may be their own lexicographer, where it states that the exceptions to giving the words in a claim their ordinary meaning in the art, the applicant must clearly set forth a special definition of a claim term in the specification that differs from the plain meaning and ordinary meaning it would otherwise possess.
The specification does not provide a clear definition as to what an “impregnation rate” means.
While [0085] recites “The above-mentioned impregnation rate refers to the impregnation rate of the material M’ in the region of the test chip 1 that is made of that material M’ over the entire thickness direction.” this is not a clear definition. [0085] further describes where the impregnation rate may be adjusted by regulating the amount of hydrophobic material to be impregnated.
Additionally, [0133]-[0135] describe the impregnation rate, where [0134] states that the impregnation rate is calculated as (P/Pmax)*100 where this describes how to obtain the impregnation rate, but is not a clear definition as to what it means.
Further, attention is brought to commonly assigned patent 12,766,504, which has also been discussed in the double patenting rejection below.
In the instant specification, [0133]-[0136] and Table 6 describe the impregnation rate, where first a filter paper has its dry mass measured M0 (g) and then is immersed in hydrophobic material and is then weighed after excess hydrophobic material is removed M1, where Pmax (g/m2) per unit section area is calculated from (M1-M0)*1000. Then it is described that the maximum and minimum thicknesses of the first and second hydrophobic film are selected and the ink densities are used to calculate actual impregnation amount P (g/m2). Where the impregnation rate (%) is calculated as (P/Pmax)*100 and the results are in Table 6.
This is appears to be the same way that ‘504 describes the impregnation ratio starting at [0121] where Pmax is calculated and [0124] describes that the impregnation ratio (%) of the hydrophobic material on the filter paper is calculated from (P/Pmax)*100. Also see Table 3.
Therefore, was “impregnation rate” meant to be “impregnation ratio”?
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, 6-8, 10, 13 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by 이창수 (KR-101493051-B1) (translated to be Changsoo Lee, and herein will be referred to as Lee).
Regarding claim 1, Lee teaches a sheet-shaped test chip (Figure 8) comprising:
a first layer on a front surface side (upper-section; Figure 8) and a second layer on a back surface side (lower-section; Figure 8);
wherein the first layer (upper-section) and the second layer (lower-section) do not have any intervening objects and are adjacent to each other ([0058] describes related embodiment seen in Figure 6 where a wax pattern is printed through double-sided printing so that patterns faced the front and back sides of 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 formed the same way and thus the upper-section and lower-section will not have any intervening objects and are adjacent to each other);
wherein one of the first layer (upper-section) has a liquid receiving section A (see annotated Figure 8 below, where the upper-section and lower-section together form the 3D view. For clarity, components are labeled in either the upper-section or lower-section, and the arrows point to the corresponding area in the 3D view);
wherein the first layer (upper-section) has at least a detection confirmation section B (see annotated Figure below);
wherein the second layer (lower-section) has at least a liquid flow section D adjacent to the detection confirmation section B, and a liquid passage E connected to the liquid flow section D (see annotated Figure below);
wherein, when the liquid receiving section A is provided in the first layer (upper-section), the liquid receiving section A is spaced from the detection confirmation section B (see annotated Figure below);
wherein, when a sample test liquid is dropped into the liquid receiving section A, the test liquid passes through the liquid receiving section A, the liquid passage E, and the liquid flow section D in the stated order, by means of capillary action, and flows to the detection confirmation section B (see Figure 9 showing fluid flow through the device of Figure 8);
wherein the sheet-shaped test chip is a single sheet that is not folded (Figures 8-9 are not seen to be folded);
wherein the liquid receiving section A, the liquid passage E, the liquid flow section D, and the detection confirmation section B, are made of a material M that permits flow of the test liquid by means of capillary action ([0061] see pattern printed on opposite sides of the paper); and the part other than the material M is made of a material M' in which the material M is impregnated with a hydrophobic material that prohibits flow of the test liquid ([0058] see wax pattern);
wherein the hydrophobic material is a wax ([0058] see wax pattern);
wherein the first layer (upper-section) consists only of a region made of the material M over the entire thickness direction and a region made of the material M' over the entire thickness direction (Figures 7-8); and
wherein the second layer (lower-section) consists only of a region made of the material M over the entire thickness direction and a region made of the material M' over the entire thickness direction (Figures 7-8).
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Regarding claim 6, Lee teaches the test chip according to claim 1. Lee further teaches wherein:
the first layer (upper-section) comprises the liquid receiving section A that is spaced from the detection confirmation section B, the second layer (lower-section) comprises a liquid flow section C adjacent to the liquid receiving section A (see annotated Figure 8 below); and
the test chip is configured such that, when the sample test liquid is dropped into the liquid receiving section A, the test liquid passes through the liquid receiving section A, the liquid flow section C, the liquid passage E, and the liquid flow section D in this order, due to the capillary action and flows to the detection confirmation section B (see annotated Figure 8 below and Figure 9).
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Regarding claim 7, Lee teaches the test chip according to claim 1. Lee further teaches wherein:
the first layer comprises (upper-section) the liquid receiving section A that is spaced from the detection confirmation section B, and a liquid passage F that is connected to the liquid receiving section A (see annotated Figure 8 below, where liquid passage F is more specifically the downward path that fluid will have to take from liquid receiving section A to the liquid passage E that is still within the upper-section); and
the test chip is configured so that, when the test liquid is dropped into the liquid receiving section A, the test liquid passes through the liquid receiving portion A, the liquid passage F, the liquid passage E, and the liquid flow section D in this order, due to the capillary action (see annotated Figure 8 below and Figure 9).
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Regarding claim 8, Lee teaches a sheet-shaped test chip (Figure 8) comprising:
a first layer on a front surface side (upper-section; Figure 8) and a second layer on a back surface side (lower-section; Figure 8);
wherein the first layer (upper-section) and the second layer (lower-section) do not have any intervening objects and are adjacent to each other ([0058] describes related embodiment seen in Figure 6 where a wax pattern is printed through double-sided printing so that patterns faced the front and back sides of 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 formed the same way and thus the upper-section and lower-section will not have any intervening objects and are adjacent to each other);
wherein one of the second layer (lower-section) has a liquid receiving section A (see annotated Figure 8 below, where the upper-section and lower-section together form the 3D view. For clarity, components are labeled in either the upper-section or lower-section, and the arrows point to the corresponding area in the 3D view);
wherein the first layer (upper-section) has at least a detection confirmation section B (see annotated Figure below);
wherein the second layer (lower-section) has at least a liquid flow section D adjacent to the detection confirmation section B, and a liquid passage E connected to the liquid flow section D (see annotated Figure below);
wherein, when the liquid receiving section A is provided in the first layer (upper-section), the liquid receiving section A is spaced from the detection confirmation section B (see annotated Figure below);
wherein, when a sample test liquid is dropped into the liquid receiving section A, the test liquid passes through the liquid receiving section A, the liquid passage E, and the liquid flow section D in the stated order, by means of capillary action, and flows to the detection confirmation section B (see Figure 9 showing fluid flow through the device of Figure 8);
wherein the sheet-shaped test chip is a single sheet that is not folded (Figures 8-9 are not seen to be folded);
wherein the liquid receiving section A, the liquid passage E, the liquid flow section D, and the detection confirmation section B, are made of a material M that permits flow of the test liquid by means of capillary action ([0061] see pattern printed on opposite sides of the paper); and the part other than the material M is made of a material M' in which the material M is impregnated with a hydrophobic material that prohibits flow of the test liquid ([0058] see wax pattern);
wherein the hydrophobic material is a wax ([0058] see wax pattern);
wherein the first layer (upper-section) consists only of a region made of the material M over the entire thickness direction and a region made of the material M' over the entire thickness direction (Figures 7-8); and
wherein the second layer (lower-section) consists only of a region made of the material M over the entire thickness direction and a region made of the material M' over the entire thickness direction (Figures 7-8).
Cho further teaches wherein the second layer (lower-section) comprises the liquid receiving portion A (see annotated Figure 8 below).
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Regarding claim 10, Lee teaches the test chip according to claim 1. Lee further teaches wherein the material M is a filter paper ([0038] describes where the paper used is Whatman 3MM chromatography paper, which is a specific type of filter paper).
Regarding claim 13, Lee teaches the test chip according to claim 1. Lee further teaches wherein a color development reaction due to a substance to be detected takes place in the detection confirmation section B ([0064] describes Figure 9C where as 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 confirmation section B as described supra).
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.
Claim(s) 10 is/are alternatively rejected under 35 U.S.C. 103 as being unpatentable over 이창수 (KR-101493051-B1) (translated to be Changsoo Lee, and herein will be referred to as Lee) in view of Zhou (US-2015/0367341-A1).
Regarding claim 10, Cho teaches the test 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 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.
Claim(s) 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over 이창수 (KR-101493051-B1) (translated to be Changsoo Lee, and herein will be referred to as Lee).
Regarding claim 12, Lee teaches the test chip according to claim 1.
Lee further describes in [0007] that the printed wax pattern that forms the three-dimensional flow path on both sides of the paper where the following is satisfied:
1. Hhf + Hhb ≥ THK
2. Hhb <THK
3. Hhf <THK
Where Hhf if the height of the front wax pattern after heating and Hhb is the height of the back wax pattern after heating, and THK is the thickness of the paper after heating. Additionally, [0007] describes that the wax penedtrated deeply in the paper and the wax penetrated from the front and wax penetrated from the rear meet each other under the condition that Hhf + Hhb ≥ THK. Further see Figure 5 which shows examples of when the wax is well heated and Hhf + Hhb ≥ THK, and an example when there is imperfect heating and Hhf + Hhb < THK. If the imperfect-heated figure were to be well-heated, one skilled in the art would find it obvious that the front wax pattern and back wax pattern would meet in the middle.
It would have been obvious to one of ordinary skill in the art at the time the invention was filed, to determine, through routine experimentation, the optimum ratio of the thicknesses of the second layer to the thickness of the first layer to a range of 0.56 to 2.2 which would allow for the formation of the three-dimensional flow path (MPEP § 2144.05 (II)).
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1, 6, 8, 10-11, 13 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3, 6-7 of U.S. Patent No. 12,766,504. Although the claims at issue are not identical, they are not patentably distinct from each other because:
Regarding claim 1, Patent 12,766,504 teaches a sheet-shaped test chip (claim 1 line 1) comprising:
a first layer on a front surface side and a second layer on a back surface side (claim 1 line 2);
wherein the first layer and the second layer do not have any intervening objects and are adjacent to each other (claim 1 line 3 where first and second layer are adjacent, further see claim 1 lines 15-16 where parts other than parts made of material M are made of material in which distribution of test liquid is not expressed, and claim 1 lines 24-25 where the material in which distribution of test liquid is not expressed is material M’ which is obtained by impregnating the material M with a hydrophobic material, therefore there would be no intervening objects as there is only material M and M’);
wherein one of the first layer and second layer has a liquid receiving section A (claim 1 line 4);
wherein the first layer has at least a detection confirmation section B (claim 1 line 5);
wherein the second layer has at least a liquid flow section D adjacent to the detection confirmation section B, and a liquid passage E connected to the liquid flow section D (claim 1 lines 6-7);
wherein, when the liquid receiving section A is provided in the first layer, the liquid receiving section A is spaced from the detection confirmation section B (claim 1 lines 8-9);
wherein, when a sample test liquid is dropped into the liquid receiving section A, the test liquid passes through the liquid receiving section A, the liquid passage E, and the liquid flow section D in the stated order, by means of capillary action, and flows to the detection confirmation section B (claim 1 lines 17-20);
wherein the liquid receiving section A, the liquid passage E, the liquid flow section D, and the detection confirmation section B, are made of a material M that permits flow of the test liquid by means of capillary action (claim 1 lines 13-14); and the part other than the material M is made of a material M' in which the material M is impregnated with a hydrophobic material that prohibits flow of the test liquid (claim 1 lines 15-16 and 24-25);
wherein the first layer consists only of a region made of the material M over the entire thickness direction and a region made of the material M' over the entire thickness direction (claim 1 lines 12-16 which describes that A, E, D, and B are made of material M and parts other than those made of material M are made of a material in which distribution of test liquid is not expressed, claim 1 lines 24-25 where the material in which distribution of test liquid is not expressed is material M’ obtained by impregnating material M with a hydrophobic material. Therefore, the first layer will either be material M or M’); and
wherein the second layer consists only of a region made of the material M over the entire thickness direction and a region made of the material M' over the entire thickness direction (claim 1 lines 12-16 which describes that A, E, D, and B are made of material M and parts other than those made of material M are made of a material in which distribution of test liquid is not expressed, claim 1 lines 24-25 where the material in which distribution of test liquid is not expressed is material M’ obtained by impregnating material M with a hydrophobic material. Therefore, the second layer will either be material M or M’).
With regards to the limitation wherein the sheet-shaped test chip is a single sheet that is not folded, claim 1 of ‘504 describes a sheet-shaped testing chip where there is a first layer on one surface side and a second layer on another surface side, where more specifically the first layer is formed on one side of a sheet of sheet-shaped material and the second layer is formed on the other side of the sheet-shaped material. Therefore, the invention of ‘504 is a single sheet, and encompasses “not folded” as the layers are formed on a sheet-shaped material, where a sheet-shaped material is flat.
With regards to the limitation wherein the hydrophobic material is a wax, claim 1 of ‘504 only describes that the material in which distribution of the test liquid is not expressed is material M’ which is obtained by impregnating the material M with a hydrophobic material. In the specification for ‘504, [0042] describes that the hydrophobic material is not limited as long as it can be impregnated into the material M and examples include wax or a composition containing wax, and [0111] describes an experiment where paraffin wax, synthetic wax, carbon black as a coloring agent, and resin ([0076] describes resin as a viscosity adjusting component) are blended to prepare the hydrophobic material. Therefore, recitation of “hydrophobic material” in claim 1 of ‘504 will encompass wax.
Regarding claim 6, ‘504 teaches:
the first layer comprises the liquid receiving section A that is spaced from the detection confirmation section B, the second layer comprises a liquid flow section C adjacent to the liquid receiving section A (claim 2 lines 2-4); and
the test chip is configured such that, when the sample test liquid is dropped into the liquid receiving section A, the test liquid passes through the liquid receiving section A, the liquid flow section C, the liquid passage E, and the liquid flow section D in this order, due to the capillary action and flows to the detection confirmation section B (claim 2 lines 6-9).
Regarding claim 8, ‘504 teaches wherein the second layer comprises the liquid receiving portion A (claim 1 line 4 where either the first or second layer has liquid-receiving section A).
Regarding claim 10, ‘504 teaches wherein the material M is a filter paper (claim 3).
Regarding claim 11, ‘504 teaches wherein the material M' has an impregnation rate of the hydrophobic material into the material M of 14% or more and 32% or less (claim 1 lines 31-32 and see claim 6).
Please note that even though claim 11 is to an “impregnation rate” and claims 1 and 6 of ‘504 are directed to an “impregnation ratio”, it is believed that ‘504 encompasses the limitation of claim 11.
In particular, [0054] of ‘504 describes where the impregnation ratio in which the material M is impregnated with a hydrophobic material to obtain the material M’ is preferably 14% or more and 70% or less, and [0055] describes that the impregnation ratio can be considered to be 100% for material M’ that is obtained by dipping material M into a hydrophobic material heated to a sufficiently low viscosity (e.g., heated at 120 °C) and maintaining the temperature for a sufficient time (e.g., 3 minutes).
It is respectfully noted that in the instant specification, [0133]-[0136] and Table 6 describe the impregnation rate, where first a filter paper has its dry mass measured M0 (g) and then is immersed in hydrophobic material and is then weighed after excess hydrophobic material is removed M1, where Pmax (g/m2) per unit section area is calculated from (M1-M0)*1000. Then it is described that the maximum and minimum thicknesses of the first and second hydrophobic film are selected and the ink densities are used to calculate actual impregnation amount P (g/m2). Where the impregnation rate (%) is calculated as (P/Pmax)*100 and the results are in Table 6.
This is appears to be the same way that ‘504 describes the impregnation ratio starting at [0121] where Pmax is calculated and [0124] describes that the impregnation ratio (%) of the hydrophobic material on the filter paper is calculated from (P/Pmax)*100. Also see Table 3.
Was the “impregnation rate” of the instant invention intended to be an “impregnation ratio”?
Regarding claim 13, ‘504 teaches wherein a color development reaction due to a substance to be detected takes place in the detection confirmation section B (claim 7).
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
