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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 02/09/2026 has been entered.
Response to Amendment
Applicant amendments filed 02/09/2026 have been entered. Applicant amendments overcomes the previous claim objection set forth in the Office Action mailed 12/29/2025, the previous claim objection is withdrawn.
Status of Claims
Claims 1-8 and 10-15 remain pending in the application, with claims 1, 6-8, 10-13 being examined and claims 2-5 and 14-15 being withdrawn pursuant to the election filed 08/01/2025.
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) 1, 6-8, 10-13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Vella (US-2016/0207038-A1) in view of Crooks (US-2017/0173578-A1).
Regarding claim 1, Vella teaches a sheet-shaped test chip comprising:
a first layer on a front surface side and a second layer on a back surface side (see annotated Figure 2B below, where the part of the substrate 13 above the dashed line is the first layer and the part of the substrate below the dashed line is the second layer);
wherein the first layer and the second layer do not have any intervening objects and are adjacent to each other (annotated Figure 2B);
wherein the sheet-shaped test chip is formed by forming the first layer on one surface (first surface 12) of a single sheet-shaped material (hydrophilic substrate 13), and forming the second layer on the other surface (second surface 14) of the sheet-shaped material (13), the sheet-shaped material (13) being made of a material M that permits flow of the test liquid by means of capillary action ([0026], [0036] see substrate may be filter paper, Figure 2A);
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Figure 7 shows a microfluidic device 700 where the method of forming the microfluidic device is illustrated in Figures 2A-B, and the device includes a substrate 701 patterned with a sample receiving region 703, assay region 707, and channel region 705, where the liquid-impervious barrier may define boundary 709 of the channel region ([0035]). It is described by [0028] that a hydrophobic material 11 is deposited on first surface 12 in a predetermined pattern 15 and depositing a hydrophobic material 11’ in a predetermined pattern 15’ on a second surface of the substrate, where the first predetermined pattern 15 and second predetermined pattern 15’ may be the same pattern or different patterns. However, Vella does not show an example of when the predetermined patterns 15 and 15’ are different.
In the analogous art of microfluidic devices comprising a fluid inlet, fluid outlet, and hollow channel connecting the two that are made of a hydrophilic material such as paper, Crooks teaches a device with a sample deposition layer and a channel layer (Crooks; [0008], [0009], [0062]).
Specifically, Crooks teaches a sample deposition layer 100 that includes a fluid inlet 102 and a fluid outlet 104, which both comprise a region of hydrophilic material and are delimited by one or more regions of hydrophobic material 106 that surround the fluid inlet 102 and/or the fluid outlet 104 and permeate the thickness of the paper substrate forming the sample deposition layer 100 (Crooks; [0063], Figure 1A). The channel layer 200 includes a hydrophobic boundary 206 that defines a hollow channel 202, where the hydrophobic boundary 206 permeates the thickness of the paper substrate (Crooks; [0064], Figure 1A). [0073] describes where an assay reagent can be deposited in the fluid outlet, where [0074] states that the assay reagents are selected to provide a response in the presence of an analyte that is visible to the naked eye.
Examiner finds that the prior art included each element claimed (as set forth above), although not necessarily in a single prior art reference, with the only difference between the claimed invention and the prior art being the lack of actual combination of the elements within a single reference. Moreover, an ordinarily skilled artisan could have combined the elements as claimed by known methods (e.g., patterning the sample receiving region 703 and assay region 707 as pattern 15 on the first surface of the substrate, and patterning the channel region 705 as pattern 15’ on the second surface of the substrate), and that in combination, each element merely would have performed the same function as it did separately (i.e., delivering a sample from sample receiving region to assay region via a channel region), and an ordinarily skilled artisan would have recognized that the results of the combination were predictable.
Therefore, pursuant to MPEP §2143 (I), Examiner concludes that it would have been obvious to an ordinarily skilled artisan to combine the two different patterns 15 and 15’ of reference Vella with the sample deposition layer and channel layer of reference Crooks, since the result would have been predictable.
As such, to create the microfluidic device 700 seen in Figure 7 of Vella, the pattern 15 deposited on first surface 12 will look like layer 100 seen in Figure 1A of Crooks, and the pattern 15’ deposited on second surface 14 will look like layer 200 seen in Figure 1A of Crooks. The patterns will be made using a hydrophobic material, where [0024] of Vella describes that one example is a wax-based ink and further [0054] of Vella describes an example where a wax ink is used as the hydrophobic barrier. Annotated Figure 1A of Crooks appears below to better show which components the first and second layer will have.
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[0030] of Vella describes that hydrophobic material 11 and 11’ contact each other somewhere within the substrate 13, where material 11 moves along the downward arrow and 11’ moves along the upward arrow seen in Figure 2A. When the patterns 15 and 15’ are different as described in [0028], one skilled in the art would find it obvious that the patterns should meet in the middle of the substrate along its thickness so as to not disrupt the respective patterns and flow of fluid through the device. Therefore, both the first layer and second layer consist 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.
The limitation “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;” is directed to the function of the apparatus and/or the manner of operating the apparatus, all the structural limitations of the claim has been disclosed by modified Vella and the apparatus of modified Vella is capable of having a sample test liquid passing from A to E to D in that order due to capillary action. As such, it is deemed that the claimed apparatus is not differentiated from the apparatus of modified Vella (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 test chip.
The method of “wherein the sheet-shaped test chip is formed by forming the first layer on one surface of a single sheet-shaped material, and forming the second layer on the other surface of the sheet-shaped material, the sheet-shaped material being made of a material M that permits flow of the test liquid by means of capillary action” is a product-by-process limitation. Even though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process and is therefore taught by modified Vella (MPEP § 2113). The burden is on applicants to show product differences in product-by-process claims.
Regarding claim 6, modified Vella teaches the test chip according to claim 1. Modified Vella further teaches wherein:
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 (please see annotated Figure 1A of Crooks provided below, where patterns 15 and 15’ seen in Figures 2A-B will be how layers 100 and 200 of Crooks appear).
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The limitation “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.” is directed to the function of the apparatus and/or the manner of operating the apparatus, all the structural limitations of the claim has been disclosed by modified Vella and the apparatus of modified Vella is capable of having a sample test liquid passing from A to C to E to D to B in that order due to capillary action. As such, it is deemed that the claimed apparatus is not differentiated from the apparatus of modified Vella (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 test chip.
Regarding claim 7, modified Vella teaches the test chip according to claim 1. Modified Vella further teaches wherein:
the first layer comprises 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 (please see annotated Figure 1A of Crooks provided below, where patterns 15 and 15’ seen in Figures 2A-B will be how layers 100 and 200 of Crooks appear).
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The limitation “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.” is directed to the function of the apparatus and/or the manner of operating the apparatus, all the structural limitations of the claim has been disclosed by modified Vella and the apparatus of modified Vella is capable of having a sample test liquid passing from A to F to E to D in that order due to capillary action. As such, it is deemed that the claimed apparatus is not differentiated from the apparatus of modified Vella (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 test chip.
Regarding claim 8, Vella teaches a sheet-shaped test chip comprising:
a first layer on a front surface side and a second layer on a back surface side (see annotated Figure 2B below, where the part of the substrate 13 above the dashed line is the first layer and the part of the substrate below the dashed line is the second layer);
wherein the first layer and the second layer do not have any intervening objects and are adjacent to each other (annotated Figure 2B);
wherein the sheet-shaped test chip is formed by forming the first layer on one surface (first surface 12) of a single sheet-shaped material (hydrophilic substrate 13), and forming the second layer on the other surface (second surface 14) of the sheet-shaped material (13), the sheet-shaped material (13) being made of a material M that permits flow of the test liquid by means of capillary action ([0026], [0036] see substrate may be filter paper, Figure 2A);
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Figure 7 shows a microfluidic device 700 where the method of forming the microfluidic device is illustrated in Figures 2A-B, and the device includes a substrate 701 patterned with a sample receiving region 703, assay region 707, and channel region 705, where the liquid-impervious barrier may define boundary 709 of the channel region ([0035]). It is described by [0028] that a hydrophobic material 11 is deposited on first surface 12 in a predetermined pattern 15 and depositing a hydrophobic material 11’ in a predetermined pattern 15’ on a second surface of the substrate, where the first predetermined pattern 15 and second predetermined pattern 15’ may be the same pattern or different patterns. However, Vella does not show an example of when the predetermined patterns 15 and 15’ are different.
In the analogous art of microfluidic devices comprising a fluid inlet, fluid outlet, and hollow channel connecting the two that are made of a hydrophilic material such as paper, Crooks teaches a device with a sample deposition layer and a channel layer (Crooks; [0008], [0009], [0062]).
Specifically, Crooks teaches a sample deposition layer 100 that includes a fluid inlet 102 and a fluid outlet 104, which both comprise a region of hydrophilic material and are delimited by one or more regions of hydrophobic material 106 that surround the fluid inlet 102 and/or the fluid outlet 104 and permeate the thickness of the paper substrate forming the sample deposition layer 100 (Crooks; [0063], Figure 1A). The channel layer 200 includes a hydrophobic boundary 206 that defines a hollow channel 202, where the hydrophobic boundary 206 permeates the thickness of the paper substrate (Crooks; [0064], Figure 1A). [0073] describes where an assay reagent can be deposited in the fluid outlet, where [0074] states that the assay reagents are selected to provide a response in the presence of an analyte that is visible to the naked eye.
Examiner finds that the prior art included each element claimed (as set forth above), although not necessarily in a single prior art reference, with the only difference between the claimed invention and the prior art being the lack of actual combination of the elements within a single reference. Moreover, an ordinarily skilled artisan could have combined the elements as claimed by known methods (e.g., patterning the sample receiving region 703 and assay region 707 as pattern 15 on the first surface of the substrate, and patterning the channel region 705 as pattern 15’ on the second surface of the substrate), and that in combination, each element merely would have performed the same function as it did separately (i.e., delivering a sample from sample receiving region to assay region via a channel region), and an ordinarily skilled artisan would have recognized that the results of the combination were predictable.
Therefore, pursuant to MPEP §2143 (I), Examiner concludes that it would have been obvious to an ordinarily skilled artisan to combine the two different patterns 15 and 15’ of reference Vella with the sample deposition layer and channel layer of reference Crooks, since the result would have been predictable.
As such, to create the microfluidic device 700 seen in Figure 7 of Vella, the pattern 15 deposited on first surface 12 will look like layer 100 seen in Figure 1A of Crooks, and the pattern 15’ deposited on second surface 14 will look like layer 200 seen in Figure 1A of Crooks. The patterns will be made using a hydrophobic material, where [0024] of Vella describes that one example is a wax-based ink and further [0054] of Vella describes an example where a wax ink is used as the hydrophobic barrier. Annotated Figure 1A of Crooks appears below to better show which components the first and second layer will have.
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[0030] of Vella describes that hydrophobic material 11 and 11’ contact each other somewhere within the substrate 13, where material 11 moves along the downward arrow and 11’ moves along the upward arrow seen in Figure 2A. When the patterns 15 and 15’ are different as described in [0028], one skilled in the art would find it obvious that the patterns should meet in the middle of the substrate along its thickness so as to not disrupt the respective patterns and flow of fluid through the device. Therefore, both the first layer and second layer consist 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.
The limitation “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;” is directed to the function of the apparatus and/or the manner of operating the apparatus, all the structural limitations of the claim has been disclosed by modified Vella and the apparatus of modified Vella is capable of having a sample test liquid passing from A to E to D in that order due to capillary action. As such, it is deemed that the claimed apparatus is not differentiated from the apparatus of modified Vella (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 test chip.
The method of “wherein the sheet-shaped test chip is formed by forming the first layer on one surface of a single sheet-shaped material, and forming the second layer on the other surface of the sheet-shaped material, the sheet-shaped material being made of a material M that permits flow of the test liquid by means of capillary action” is a product-by-process limitation. Even though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process and is therefore taught by modified Vella (MPEP § 2113). The burden is on applicants to show product differences in product-by-process claims.
Additionally, as seen above the second layer will comprise the liquid receiving section A.
Regarding claim 10, modified Vella teaches the test chip according to claim 1. Vella further teaches wherein the material M is a filter paper (Vella; [0036]).
Regarding claim 11, modified Vella teaches the test chip according to claim 1.
The limitations of claim 11 are directed to the function of the apparatus and/or the manner of operating the apparatus, all the structural limitations of the claim has been disclosed by modified Vella and the wax-based ink is capable of having an impregnation rate into the filter paper of 14% or more and 32% or less. As such, it is deemed that the claimed apparatus is not differentiated from the apparatus of modified Vella (see MPEP §2114).
Further, while modified Vella does not address impregnation rate, 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 filter paper and the wax-based ink are different, the prior art is considered to have the same properties with respect to impregnation rate as that is claimed. MPEP § 2112.01 (I-IV).
Regarding claim 12, modified Vella teaches the test chip according to claim 1. While Vella does teach that hydrophobic material 11 and 11’ contact each other somewhere within the substrate 13, where the location of the contact will define the thickness of the first and second layer, Vella does not teach a ratio of the thickness of the second layer to the thickness of the first layer (thickness of the second layer / thickness of the first layer) is 0.56 or more and 2.2 or less.
However, there is no established criticality or evidence showing an unexpectedly good result occurring from the claimed parameters.
Therefore, it would have been obvious to one skilled in the art at the time the invention was filed, to determine, through routine experimentation, the optimum ratio of the thickness of the second layer to the first layer to a range of 0.56 to 2.2 which would allow for a desired depth of the channel region within the substrate (MPEP § 2144.05 (II)).
Regarding claim 13, modified Vella teaches the test chip according to claim 1. While Vella does teach assay region 707, Vella does not teach any specific reagents found in the assay region (Vella; [0035]).
Crooks teaches that assay reagents placed in the fluid outlet of a device can be an indicator that exhibits colorimetric and/or fluorometric response in the presence of an analyte of interest (Crooks; [0074]).
Vella is silent with regards to specific reagents found in the assay region, therefore, it would have been necessary and thus obvious to look to the prior art for conventional assay reagents. Crooks provides this conventional teaching showing that it is known in the art to use assay reagents that exhibits colorimetric response in the presence of an analyte of interest. Therefore, it would have been obvious to one having ordinary skill in the art to use the assay reagent of Crooks in the assay region of Vella because it is taught by Crooks that an assay reagent that changes color is effective for detecting an analyte of interest (Crooks; [0074]).
Response to Arguments
Applicant’s amendments to the claims and arguments, see page 9, filed 02/09/2026, with respect to the rejection(s) of claim(s) 1, 6-8, 10-13 under 35 USC 103 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Vella (US-2016/0207038-A1) and Crooks (US-2017/0173578-A1).
Conclusion
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/S.Y.L./Examiner, Art Unit 1796
/MELVIN C. MAYES/Supervisory Patent Examiner, Art Unit 1759