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 1-8, 10, 11, 21, 29, 37-40, and 52-54) in the reply filed on May 8, 2026 is acknowledged.
Claim 68 is withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.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 May 8, 2026.
Drawings
The drawings were received on March 13, 2023. These drawings are acceptable.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1-3, 6, 10, 11, 29, 37, 40, and 52 is/are rejected under 35 U.S.C. 103 as being unpatentable over Mahmud et al (US 2019/0184393 A1) in view of Garcia Da Fonseca (US 2010/0021347 A1) (hereinafter referred to as “Fonseca”) (both references provided by applicant in IDS dated 3/13/2023).
With respect to claim 1 Mahmud discloses a sample testing chip ([abstract]- A method and system for subtractive patterning of a substrate, which is utilized in the making of paper-based microfluidic analytical devices (pPADs)) comprising:
a first layer formed of a porous hydrophilic material (See para [0029)- The assembly comprises a substrate layer and an impermeable backing layer ... The substrate layer may be any absorbent material that is permeable to (or penetrable by) an etching tool, and which is hydrophilic ... the substrate layer is a paper layer, such as cellulose chromatography paper. In other embodiments, the substrate may be made of another material. For example, the material of the substrate layer may be, but is not limited to, glass fibre paper, nitrocellulose, blotting papers, polymers, or plastics. The material of the substrate layer may be of varying thicknesses and may have various pore sizes); and
one or more hydrophobic barriers located in the first layer to define one or more testing areas configured to receive a volume of a sample (See para [0037)- The subtractive pattern is formed within the penetrable substrate layer using a selected etching device. The subtractive pattern is a portion or region of the device in which the substrate has been removed to expose the impermeable layer and provide a hydrophobic barrier region which does not permit fluid flow (e.g. which is non-absorbent)).
Mahmud does not disclose one or more auxiliary areas, wherein the one or more testing areas and the one or more auxiliary areas are separated from one another by the hydrophobic barrier and are not fluidically connected.
Fonseca, drawn to microfluidic detection device (See abstract), discloses, one or more auxiliary areas (52) (See Fig. 8; para [0140]- it may be considered favourable to include an auxiliary DZ 52 also based on the SPR effect as schematically shown in FIG. 8 (for example, in order to measure a reference signal whose variation with temperature is known)), wherein the one or more testing areas (42) and the one or more auxiliary areas (52) are separated from one another and are not fluidically connected (see Fig. 8, elements 42 and 52; para [0085)- the fluid is displaced from the initial reservoir 41 to the DZ 42. This displacement of the fluid can allow the occurrence of the desired chemical and/or biological event).
It would have been obvious to a person of ordinary skill in the art to combine one or more auxiliary areas, wherein the one or more testing areas and the one or more auxiliary areas are separated from one another by the hydrophobic barrier and are not fluidically connected of Fonseca with the system of Mahmud, to reduce complexity and cost of the device (See para [0031] of Fonseca).
With respect to claim 2, applicant should note the recitation of “he one or more auxiliary areas are configured to receive a volume of liquid to provide humidity control for the sample testing chip” is directed to the function of the apparatus and/or the manner of operating the apparatus. All the structural limitations of the claim have been disclosed by modified Mahmud and the apparatus of modified Mahmud is capable of the recitation of claim 2. As such, it is deemed that the claimed apparatus is not differentiated from the apparatus of modified Mahmud (see MPEP §2114).
With respect to claim 3 the combination of Mahmud and Fonseca teaches that the size ratio between the one or more testing areas (42) and the one or more auxiliary areas (52) is in a range of 9:1 to 1:9, a range of 7:3 to 3:7, or in a range with an upper end of 9:1, 8:2, 7:3, 6:4, 5:5, 4:6, 3:7, or 2:8 and a tower end of 8:2, 7:3, 6:4, 5:5, 4:6, 3:7, 2:8, or 1 :9 (see Fig. 8 of Fonseca for the size ratio between the testing area and the auxiliary area; para [0140)- it may be considered favourable to include an auxiliary DZ 52 also based on the SPR effect as schematically shown in FIG. 8; para (0072]- Let us consider as a first example the case where the sum of the total volumes for the channels 45, valve 50 and DZ 42 is smaller than the volume of initial reservoir 41 ).
With respect to claim 6 the combination of Mahmud and Fonseca teaches that each of the one or more sample testing areas are fluidically separated from one another (See para [0037) of Mahmud- The subtractive pattern is formed within the penetrable substrate layer using a selected etching device. The subtractive pattern is a portion or region of the device in which the substrate has been removed to expose the impermeable layer and provide a hydrophobic barrier region which does not permit fluid flow (e.g. which is non-absorbent).
With respect to claim 10 the combination of Mahmud and Fonseca teaches a second layer coupled to a first surface of the porous hydrophilic layer and/or a third layer coupled to a second surface of the porous hydrophilic layer (See para [0029] of Mahmud- an assembly of a layer that is impermeable to an etching device (e.g. a laser-impermeable backing) affixed to a substrate is provided. The assembly comprises a substrate layer and an impermeable backing layer, and if required, an adhesive layer).
With respect to claim 11 the combination of Mahmud and Fonseca teaches that the second layer is in full contact with the first surface of the porous hydrophilic layer (See para [0032) of Mahmud- the impermeable layer may vary with the etching tool utilized. More particularly, a layer which is impermeable to one etching tool may not be impermeable to another etching tool. Or, a layer which is impermeable under one set of parameters (e.g. low power or high speed) of a given etching tool may not be impermeable to a different set of parameters (e.g. high power or low speed) for the same etching tool).
With respect to claim 29 the combination of Mahmud and Fonseca teaches that the one or more testing areas are configured to receive a test sample potentially comprising a lest target such that the test sample diffuses from said one or more testing areas to all other testing areas fluidically connected therewith (See para [0007], [0037) of Mahmud- The subtractive pattern may be further formed in the substrate such that the sample zone is connected to one or more hydrophilic detection or readout zones via one or more hydrophilic channels that permit fluid flow from the sample zone to the detection zone (e.g. for example, the subtractive pattern may provide an hourglass-shaped fluid flow region in the case of a single detection zone, or a shape comprising a central sample zone with multiple appendages extending therefrom in the case of two or more detection zones)).
With respect to claim 37 the combination of Mahmud and Fonseca teaches that the test target is a target molecule wherein the target molecule is naturally occurring or engineered (See para [0040] of Mahmud- Examples of such applications include, but are not limited to, biomedical diagnostics such as pregnancy tests, glucose tests, biomarker tests, etc.; environmental testing such as water testing for microbial or other contaminants (e.g. arsenic); and any complex geometric high resolution architecture for holding a sample).
With respect to claim 40 the combination of Mahmud and Fonseca teaches that the one or more testing areas and one or more control areas further comprise a test reagent (See Paras. 0040 and 0070 of Mahmud).
With respect to claim 52 the combination of Mahmud and Fonseca teaches that the test reagent is suitable for detecting a target molecule wherein the target molecule is naturally occurring or engineered (See Paras. 0040 for discussion of the use of bodily fluids as the fluid sample).
Claim(s) 38, 39, 53 and 54 is/are rejected under 35 U.S.C. 103 as being unpatentable over Mahmud et al (US 2019/0184393 A1) and Garcia Da Fonseca (US 2010/0021347 A1) in view of Lee et al (US 2020/0215538 A1) (provided by applicant in IDS dated 3/16/2023).
See above for the combined teachings of Mahmud and Fonseca.
With respect to claim 38 the combination of Mahmud and Fonseca fails to teach wherein the target molecule is a gene, a deoxyribonucleic acid (DNA), a ribonucleic acid (RNA), an oligonucleotide, a polynucleotide, or any combinations thereof, and more specifically a viral gene, and even more specifically a SARS-CoV-2 gene.
Lee teaches the target molecule is a gene, a deoxyribonucleic acid (DNA), a ribonucleic acid (RNA), an oligonucleotide, a polynucleotide, or any combinations thereof, and more specifically a viral gene, and even more specifically a SARS-CoV-2 (para [0018]The self-driven microfluidic chip of the present invention is suitable for all kinds of virus microorganism detections, and the magnetic beads may be tested for other kinds of viruses as long as the specific biological identification molecules and the primers for isothermal nucleic acid amplification of different viruses are combined; para [0039]- diagnose whether the H1N1 virus exists in the sample or not).
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to provide the target molecule is a gene, a deoxyribonucleic acid (DNA), a ribonucleic acid (RNA), an oligonucleotide, a polynucleotide, or any combinations thereof, and more specifically a viral gene, and even more specifically a SARS-CoV-2 of NTHU with the system of modified Mahmud, to develop a rapid and highly sensitive detecting method (See Para. 0051 of Lee).
With respect to claim 39 the combination of Mahmud and Fonseca fails to teach wherein the target molecule is from a pathogen, and more specifically from a virus, and even more specifically from a virus selected from the group consisting of a coronavirus, an influenza virus, a parainfluenza virus, a rhinovirus virus, an adenovirus, and any combinations thereof.
Lee teaches that the target molecule is from a pathogen, and more specifically from a virus, and even more specifically from a virus selected from the group consisting of a coronavirus, an influenza virus, a parainfluenza virus, a rhinovirus virus, an adenovirus, and any combinations thereof (See Para [0039]- diagnose whether the H1N1 virus exists in the sample or not).
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to provide the target molecule is from a pathogen, and more specifically from a virus, and even more specifically from a virus selected from the group consisting of a coronavirus, an influenza virus, a parainfluenza virus, a rhinovirus virus, an adenovirus, and any combinations thereof of Lee with the system of modified Mahmud, to develop a rapid and highly sensitive detecting method (See Para. 0005 of Lee).
With respect to claims 53 and 54 the combination of Mahmud, Fonseca, and Lee teaches that the target molecule is for detecting and diagnosing the presence of influenza A virus (See Para. 0034 of Lee).
Allowable Subject Matter
Claims 4, 5, 7, 8, and 21 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter: The closest cited prior art of reference fails to disclose or teach:
The incorporation of one or more additional hydrophobic barriers located in the first layer to define one or more control areas fluidically separated from the one or more testing areas, wherein the one or more control areas form a fluidic connection with at least one of said auxiliary areas (claim 4); claim 5 is dependent upon claim 4 and inherits the same status;
That at least one of the one or more sample testing areas forms a fluidic connection with at least one other of said one or more sample testing areas (claim 7);
That at least one of the one or more auxiliary area forms a fluidic connection with at least one other of said one or more auxiliary areas (claim 8); and
a volume located between the third layer and the first layer configured to encapsulate air, a gas, or vapor, wherein the volume is sealed between the third layer and the first layer (claim 21).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRITTANY I FISHER whose telephone number is (469)295-9182. The examiner can normally be reached IFP.
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, James Lin can be reached at (571) 272-8902. 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.
/BRITTANY I FISHER/Examiner, Art Unit 1796 June 13, 2026
Prosecution Insights