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 Amendment
Applicant amendments filed 04/17/2026 have been entered.
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and 10-15 remain pending in the application, with claims 1, 6-8, 10-13 being examined and claims 2-5 and 14-15 being withdrawn pursuant to the election filed 08/01/2025.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 a single sheet that is not folded (as seen in Figure 2B the substrate 13 is not folded);
PNG
media_image1.png
385
556
media_image1.png
Greyscale
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]). Further [0036] describes that the substrate may be filter paper. 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. The substrate 13 of Vella is filter paper and will permit capillary action. Annotated Figure 1A of Crooks appears below to better show which components the first and second layer will have.
PNG
media_image2.png
425
643
media_image2.png
Greyscale
[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.
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).
PNG
media_image3.png
482
679
media_image3.png
Greyscale
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).
PNG
media_image4.png
460
664
media_image4.png
Greyscale
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 a single sheet that is not folded (as seen in Figure 2B the substrate 13 is not folded);
PNG
media_image1.png
385
556
media_image1.png
Greyscale
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]). Further [0036] describes that the substrate may be filter paper. 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. The substrate 13 of Vella is filter paper and will permit capillary action. Annotated Figure 1A of Crooks appears below to better show which components the first and second layer will have.
PNG
media_image5.png
488
678
media_image5.png
Greyscale
[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.
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 arguments filed 04/17/2026 have been fully considered but are not persuasive. Due to applicant amendments to the claims, the rejections in view of Vella and Crooks under 35 USC 103 have been modified to address this amendment.
In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
In particular, applicant makes arguments on page 11 directed to Vella’s Figure 7 not teaching the various components of the sheet-shaped test chip.
It is respectfully noted that the structure seen in Figure 7 of Vella is not being used to teach the liquid receiving section A, detection confirmation section B, liquid flow section D. Vella is being used for its teachings regarding patterning a substrate with a wax-based ink, specifically where the patterns on either side of the substrate may be different. Crooks is being used for teaching the different patterns that will be printed on either side of the substrate, please see the annotated Figure of Crooks supra which points to the various areas being mapped to. In particular, on page 6 of this office action as well as page 6 of the office action mailed 03/04/2026, it describes that the pattern 15 deposited on the first surface 12 will look like layer 100 seen in Figure 1A of Crooks and the pattern 15’ deposited on the second surface will look like layer 200 seen in Figure 1A of Crooks. The dark shaded areas of Crooks seen in Figure 1A is the hydrophobic material.
Applicant argues on page 12 that that the material M’ does not penetrate through the entire thickness of the test chip, and references Figures 1B, 2B, an 3D of Vella which shows the barrier 17 extending from the top surface to the bottom surface of the substrate 13.
Examiner does agree that the Figures of Vella do show the barrier extending from the top of the substrate 13 to the bottom, however it is respectfully noted that [0028] of Vella (cited above) describes that the patterns 15 and 15’ seen in Figure 2A may be different from one another, and further [0030] of Vella (cited above) describes that the hydrophobic material 11 and 11’ contact each other somewhere within the substrate 13. As stated in the rejection supra, one skilled in the art would find it obvious that when the patterns 15 and 15’ are different from each other, they should still meet each other somewhere in the middle of the substrate along its thickness so as to not disrupt the respective patterns and flow of fluid through the device. In other words, the result of the different patterns 15 and 15’ will not result in the barrier looking like 2B, rather the hydrophobic material of either pattern will still meet somewhere in the middle of the substrate 13.
Applicant argues on page 13 that Figure 4 of Vella shows that after depositing hydrophobic material on a surface of the hydrophilic substrate the process requires allowing or causing the hydrophobic material to permeate within the substrate between the first surface and second surface of the substrate.
Examiner does agree that this is what Figure 4 states, however with the description of [0028] and [0030], the patterns being different and meeting somewhere in the middle of the substrate would also have the hydrophobic material permeating within the substrate between the first surface and second surface. In other words, the hydrophobic material is not required to permeate the substrate like how it is seen in Figure 2B to permeate between the first surface and second surface. If the hydrophobic material 11 seen in Figure 2A stops in the middle of the substrate 13, it would still be permeated between the first and second surfaces.
With regards to applicant arguments on page 14 that Crooks teaches folding the paper-based substrate, it is respectfully noted that Crooks is not being used for teaching folding. Crooks is being used specifically for the patterns of hydrophobic material.
Other References Cited
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Translated 이창수 (understood to be Changsoo Lee when translated) (KR-101493051-B1) teaches a microchannel designed with a wax pattern that was printed through double-sided printing so that the patterns faced the front and back sides of the paper (Lee; [0058], Figure 6).
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
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.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/S.Y.L./Examiner, Art Unit 1796
/MELVIN C. MAYES/Supervisory Patent Examiner, Art Unit 1759
Prosecution Insights