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 election with traverse of Group I, claims 91-98, in the reply filed 09/04/2026 is acknowledged. The traversal is on the grounds that the Office has failed to consider all the elements of the pending claims – specifically micropillar diameter, micropillar separation, array area, micropillar height, and micropillar arrangement. This is not found to be persuasive because these technical features are present in the prior art (See Claim 91 Rejection – 35 USC § 102).
The requirement is still deemed proper and is therefore made FINAL.
Claims 99-110 (Group II) are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.
Priority
Receipt is acknowledged of certified copies of papers of provisional application (63/242,216) filed on 09/09/2021.
Information Disclosure Statement
The information disclosure statements (IDS) filed on 06/17/2024 and 05/30/2025 have been certified and made of record.
Specification
The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code. Specifically, the hyperlink “https://doi.org/10.3390/mi2030319” is present in the Detailed Description of the specification (p. 12 of the specification). Applicant is required to delete the embedded hyperlink and/or other form of browser-executable code; references to websites should be limited to the top-level domain name without any prefix such as http:// or other browser-executable code. See MPEP § 608.01.
Claim Objections
Claim 96 is objected to because of the following informalities:
The claim limitation “wherein the device comprises at least 6, 12, 8, 12” is repeated and should read “wherein the device comprises at least 6, 8, 12…”. Appropriate correction is required.
Claim Rejections - 35 USC § 112
Claims 91-98 are 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. Specifically, the claim limitation “defined configuration” is identified as the configuration used for the arrangement of the micropillars within the array. However, the specific structure for what comprises a “defined configuration” for the pillars is unclear. Claims 92-98 depend on claim 91 and fail to cure the deficiencies of the independent, and therefore, are included in the 35 U.S.C. 112(b) rejection. For examination purposes, a “defined configuration” will be interpreted as micropillars in a bounded area.
Regarding claims 97 and 98, the phrase "for example" renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d). Specifically, claims 97 and 98 include exemplary language (e.g.), which is considered indefinite.
Claim Rejections - 35 USC § 102
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.
Claims 91-93, 96, 97 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Toner et al. (US 20120006760 A1) (referenced in IDS – dated 06/17/2024).
Regarding claim 91, Toner et al. teaches a microfluidic flow-based device (See annotated FIG. 8 below), comprising:
at least one microfluidic channel having at least one inlet port (Annotated FIG. 8) and at least one outlet port (Annotated FIG. 8) to allow a flow in a direction from the inlet port toward the outlet port (Annotated FIG. 8); and
at least one array of micropillar disposed within the microfluidic channel (Annotated FIG. 8) wherein:
the micropillars have diameters between 3 micrometers and 50 micrometers (FIG. 9 – micropost diameter is 50 µm); the micropillars are separated from each other by spacing between 2 micrometers and 150 micrometers (50 µm separation);
the array is bounded within an area between 1 square millimeter and 1600 square centimeters (FIG. 9 – area of array falls within range from dimensions);
the micropillars have a height between 1-200 µm (FIG. 9 – 100 µm);
the micropillars are arranged within the array in a defined configuration (FIG. 9 – micropillars in a bounded area)
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Regarding the limitation “for extracting fragment of genomic DNA in a selected size range from a cell or cell nucleus”, it has been established “a claim containing a “recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus” if the prior art apparatus teaches all the structural limitations of the claim” (MPEP § 2114 II). The prior art apparatus taught by Toner et al. teaches all the structural limitations of the claim, and although Toner et al. teaches the microfluidic flow device (FIG. 8/FIG. 9) for separating cells from a sample (e.g., separating fetal red blood cells from maternal blood), the micropillars would be structurally capable of extracting fragments of genomic DNA in a selected size range from a cell or cell nucleus.
Regarding claim 92, Toner et al. teaches the device of claim 91. Toner et al. teaches micropillars with circular shapes (FIG. 9).
Regarding claim 93, Toner et al. teaches the device of claim 91. Toner et al. teaches that the device can contain obstacles distributed, e.g., in an ordered array or randomly, throughout the flow chamber (para. [0072]).
Regarding claim 96, Toner et al. teaches the device of claim 91. Toner et al. teaches a device of eight parallel processing channels (para. [0059]).
Regarding claim 97, Toner et al. teaches the device of claim 91. Toner et al. teaches a lysis device that can further comprises a wash buffer “The device can be functionally separated into four distinct sections: 1) distributed input channels carrying fluids, e.g., blood, lysis reagent, and wash buffer” (para. [0055]).
Claim Rejections - 35 USC § 103
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.
Claims 94 and 95 are rejected under 35 U.S.C. 103 as being unpatentable over Toner et al. (already referenced) in view of Craighead et al. (US 20210189381 A1) (referenced in IDS).
Regarding claim 94, Toner et al. teaches the device of claim 91 but fails to teach micropillars disposed of in a gradient of variable spacings. Craighead et al. teaches a microfluidic device for extracting and isolating DNA from cells, which features a micropillar array with micropillars spatially configured to entrap, by size exclusion, the cell, to immobilize DNA released from the cell, and to maintain the immobilized DNA in elongated or non-elongated form when hydrodynamic force is applied to the microfluidic channel (abstract). Craighead et al. specifically teaches “The array of microposts (5 μm wide and 20 μm tall) was designed with a gradient in spacing to create a solid obstacle for cell capture” (para. [0119]). As seen in FIG. 1, this gradient is a stepped gradient, changing in steps of varying gap distances.
It would have been prima facie obvious to one of ordinary skill in the art at the time of filing to use Craighead et al.’s teaching a micropost gradient in Toner et al.’s microfluidic device because the gradient spacing provided creates a solid obstacle for cell capture and entrapment (by size exclusion). This method of improving Toner et al.’s microfluidic device was within the ability of one of ordinary skill in the art based on the teachings of Craighead et al. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings of Toner et al. and Craighead et al. to obtain the invention specified in claim 94.
Regarding claim 95, Toner et al. teaches the device of claim 91 but fails to teach micropillars separated from each other by spacing of in the range of about 2 to 30 µm. Craighead et al. teaches “The array of microposts (5 μm wide and 20 μm tall) was designed with a gradient in spacing to create a solid obstacle for cell capture. The average gap between the microposts varies continuously from 15 μm to 2 μm along the channel” (para. [0119]).
It would have been prima facie obvious to one of ordinary skill in the art at the time of filing to use Craighead et al.’s teaching of microposts spaced from 15 μm to 2 μm in Toner et al.’s microfluidic device because the gap spacing provided in the gradient creates a solid obstacle for cell capture. This method of improving Toner et al.’s microfluidic device was within the ability of one of ordinary skill in the art based on the teachings of Craighead et al. Furthermore, as established in MPEP § 2144.05, where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. The claimed range of spacing (2 to 30 µm) falls within the gap range disclosed by Craighead et al. (15 μm to 2 μm along the channel), and therefore, a prima facie case of obviousness exists. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings of Toner et al. and Craighead et al. to obtain the invention specified in claim 95.
Claim 98 is rejected under 35 U.S.C. 103 as being unpatentable over Toner et al. (already referenced) in view of Abate et al. (US 20170009274 A1) (referenced in 892).
Regarding claim 98, Toner et al. teaches the device of claim 91 but fails to teach one instrument that facilitates DNA cleavage and/or DNA release from the channel (such as a light source). Abate et al. teaches microfluidic devices and methods (abstract), wherein Abate et al. teaches that the microfluidic devices can use optical scanners (para. 0327]). Abate et al. specifically teaches that optical scanners (laser light source) and focused on the microfluidic channel can excite fluorescent dyes, as scanning one more discrete entities may allow one or more properties, e.g., size, shape, composition, of the scanned entities to be determined (para. 0327]).
It would have been prima facie obvious to one of ordinary skill in the art at the time of filing to use Abate et al.’s teaching of optical scanners (light source) in Toner et al.’s microfluidic device because the optical scanners can excite fluorescent dyes and scan for properties (size, shape, composition). This method of improving Toner et al.’s microfluidic device was within the ability of one of ordinary skill in the art based on the teachings of Abate et al. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings of Toner et al. and Abate et al. to obtain the invention specified in claim 98.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JULIUS FRANCIS YOH whose telephone number is (571)272-3489. The examiner can normally be reached Monday-Friday: 7:30-5 PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Marcheschi can be reached at 571-272-1374. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JULIUS FRANCIS YOH/Examiner, Art Unit 1799
/William H. Beisner/Primary Examiner, Art Unit 1799
