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 with traverse of Group I, claims 1-6, in the reply filed on February 13, 2026 is acknowledged. The traversal is on the ground(s) that the previous Office Action did not establish an undue search burden of the claims as specified by MPEP 803. This is not found persuasive because the instant application is a national stage entry filed under 35 U.S.C. 371 and is therefore not subject to US restriction practice but rather subject to lack of unity practice, see MPEP 1893.03(d). It is noted that undue search burden is not a criterion in lack of unity analysis. The test is whether or not special technical features can be established. It is noted that inventions listed as Groups I-IV do not relate to a single general inventive concept under PCT Rule 13.1 because, under PCT Rule 13.2, they lack the same or corresponding special technical features as set forth on page 4 of the previous Office Action.
The requirement is still deemed proper and is therefore made FINAL.
Claims 7-9, 11-14, and 17-23 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to nonelected inventions, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 2/13/2026.
Drawings
The drawings were received on 5/22/2023. These drawings are acceptable.
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.
Claims 2 and 5 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 2 recites the limitation "said virus" in line 1. There is insufficient antecedent basis for this limitation in the claim.
Claim 5 recites the limitation "LED" in line 2. There is insufficient antecedent basis for this limitation in the claim. For the purpose of examination, it is being interpreted that the applicant is referring to the recited “light source” in claim 4.
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 and 2 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Wilson et al (WO 2019/246229 A1) (reference will be made to US 2021/0268500 A1).
With respect to claim 1 Wilson discloses a device (fluidic device, See abstract) for detecting and/or quantifying a coronavirus comprising a paper microfluidic chip (See Para. 0117 for discussion of how the fluidic device(s) can included five paper layers), comprising one or more microfluidic channels (See Fig. 6A and Para. 0117), wherein said paper has a pore size of about 5 µm to 15 µm (See Para. 0087 for discussion of the porous materials having an average pore size greater than or equal to 5 microns, greater than or equal to 10 microns, greater than or equal to 15 microns), and wherein said channels have a width about 2 mm to about 5 mm (See Para. 0074 for discussion of the channels having a width greater than or equal to 2mm or less than or equal to 5mm) and/or a channel length between channel length of about 20 mm to about 50 mm (See Para. 0075 for discussion of the suitable aspect ratios of channel length relative to the channel width, which can be greater than or equal to 10:1, 20:1, etc.).
With respect to claim 2, applicant should note these limitations are 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 Wilson and the apparatus of Wilson is capable of the recitation of claim 2. As such, it is deemed that the claimed apparatus is not differentiated from the apparatus of Wilson (see MPEP §2114).
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) 3 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wilson et al (WO 2019/246229 A1) (reference will be made to US 2021/0268500 A1) in view of Delahunt et al (US 2015/0111216 A1).
Refer above for the disclosure of Wilson.
With respect to claim 3 Wilson fails to disclose that the device further comprises a benchtop fluorescence microscope.
Delahunt teaches a devices and methods for preparing and assessing a liquid sample are described which include: a microfluidic microscopy device including an absorbent structure including at least one dry dye for a liquid and configured to convey a polar liquid from a first end of the absorbent structure through the at least one dry dye for a liquid to a second end of the absorbent structure (See abstract). The method includes providing a microscope as an optical detector. In an aspect, the method includes providing a laboratory light microscope. Non-limiting examples of microscopy techniques for use with a light microscope include bright field microscopy, dark field microscopy, phase contrast microscopy, and fluorescence microscopy. In an aspect, the microfluidic microscopy device is sized to fit on a microscope specimen stage, as described above herein. In an aspect, the microscope can include a field-portable, lens-free microscope (See Para. 0167).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed inventio to incorporate the benchtop fluorescence microscope taught by Delahunt into the device of Wilson such that a user can utilize a field-portable, lens-free microscope to detect desired properties of a collected sample (See Para. 0167 of Delahunt).
Claim(s) 3-6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wilson et al (WO 2019/246229 A1) (reference will be made to US 2021/0268500 A1) in view of Yoon et al (US 2021/0129143 A1) (filed 10/28/2020).
Refer above for the disclosure of Wilson.
With respect to claim 3 Wilson fails to disclose that the device further comprises a benchtop fluorescence microscope.
Yoon teaches devices and kits for enteric virus detection using paper analytic device by directly imaging and counting on-paper aggregation of antibody-conjugated, fluorescent submicron particles (See abstract), wherein the device also comprises a benchtop fluorescence microscope (See Para. 0026). Through size analysis, the locations of fluorescent particles (both non-aggregated and aggregated) could easily be determined, which showed the pixel intensities of at least 100 (out of 255). Distinction could also be made between non-aggregated and aggregated particles using the pixel area of 50. Therefore, the raw images were processed to eliminate the pixels with <100 intensity (to remove background) and the pixel area <50 (to remove non-aggregated particles) (See Para. 0132).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate the benchtop fluorescence microscope taught by Yoon into the device of Wilson so that distinction and location can be more easily made and determined between different particles.
With respect to claim 4 Wilson fails to disclose that the device further comprises a smartphone-based fluorescence microscope comprising a smartphone, a microscope attachment, a light source, a battery to power said light source, and an optical filter.
Yoon teaches devices and kits for enteric virus detection using paper analytic device by directly imaging and counting on-paper aggregation of antibody-conjugated, fluorescent submicron particles (See abstract), wherein the device also comprises a smartphone-based fluorescence microscope comprising a smartphone, a microscope attachment, a light source, a battery to power said light source, and an optical filter (See Para. 0027). The invention provides several benefits, for example, easy, inexpensive, yet extremely sensitive detection of an enteric virus such as norovirus and incorporates use smartphone which makes testing portable and can be useful in remote areas (See Para. 0022).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate the smartphone-based fluorescence microscope comprising a smartphone, a microscope attachment, a light source, a battery to power said light source, and an optical filter of Yoon into the device of Wilson such that testing can be portable, which is useful in remote areas (See Para. 0022 of Yoon).
With respect to claim 5, the combination of Wilson and Yoon teaches that said microscope attachment, light source such as an LED, battery to power said light source, and optical filter are housed within a plastic enclosure to block ambient lighting (See Para. 0030 of Yoon).
With respect to claim 6, the combination of Wilson and Yoon teaches that said microscope attachment comprises a bandpass filter or acrylic films (See Para. 0032 of Yoon).
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.
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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.
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/BRITTANY I FISHER/Examiner, Art Unit 1796 May 29, 2026
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