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 .
Status of Claims
The claim set submitted on 11 MARCH 2026 is acknowledged and considered.
In the claim set, Claims 1-77 are ‘Cancelled’ ; Claims 78, 81, 84-87, 89, 90-92 and 94-97 are ‘Currently Amended’; and Claims 79, 80, 82, 83, 88 and 93 are ‘Previously Presented’.
Current pending claims are Claims 78-97 and are considered on the merits below.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 11 MARCH 2026 was filed after the mailing date of the Non Final Office Action on 23 SEPTEMBER 2025. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Response to Amendment/Arguments
Applicant’s arguments, see REMARKS, filed 11MARCH 2026, with respect to the claim objections, the objections to the specification and drawings, the 112(b) rejections the 102 art rejections of Claim 78 and its dependent claims have been fully considered and are persuasive. The claim objections, the objections to the specification and drawings, the 112(b) rejections the 102 art rejections of Claim 78 and it dependent claims of have been withdrawn.
Applicant’s arguments with respect to claim(s) 78-89 have been considered but are moot. Applicant has amended the independent claim to further define the invention. Based the amendment to the claims the rejection below has been modified and in part relies partly on the previously applied art.
In the REMARKS filed on 11 MARCH 2026, there are no assertions regarding independent Claim 90. The art rejection for Claim 90 and its dependent claims have been maintained and reproduced below. The claim objections and the 112(b) rejections have been withdrawn from Claim 90 and its dependent claims as these were to fix informalities.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 90-94 and 96-97 are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by KAYYEM, US Publication No. 2018/0223345 A1, submitted on the Information Disclosure Statement on 18 MAY 2023; US Patent Documents Cite No. 008.
Applicant’s invention is directed towards a method.
Regarding Claim 90, the reference KAYYEM discloses a method, comprising:
(a) directing a sample comprising one or more analytes to a device, [0030, 0309], said device comprising:
an inlet configured to receive said sample, [0022, 0029, 0030, 0183];
a fluidic channel in fluidic connection with said inlet and a fluidic region downstream of said inlet, said fluidic channel configured to passively or actively flow said sample from said inlet to said fluidic region upon receipt of said sample, [0039, 0183, 0194];
wherein said fluidic region comprises at least one composite electrode adjacent to and operably coupled to said fluidic region, wherein said at least one composite electrode is configured to enrich [[for]] said one or more analytes from said sample in said fluidic region, [01, 0113, 0116, 0117, 0135];
(b) passively or actively flowing said sample from said inlet to said fluidic region via said fluidic channel, [0194, 0196, 0112, 0113], Figure 25A, B; and
(c) enriching for said one or more analytes from said sample in said fluidic region, [0113], Figure 25A, B.
Additional Disclosures Included are: Claim 91: wherein the method of claim 90, wherein said enriching [[for]] said one or more analytes comprises applying an electric field to said sample, [0112, 0141]. ;Claim 92: wherein the method of claim 90, further comprising: subjecting said one or more analytes to one or more reactions Claim 93: wherein the method of claim 92, further comprising: detecting said signal from said fluidic region, thereby determining said presence or absence of said analyte in said sample, [0117, 0129]. ; Claim 94: wherein the method of 92, wherein said one or more analytes comprises one or more nucleic acids, and wherein said one or more reactions comprises an isothermal amplification reaction of said one or more nucleic acids, [0110, 0121, 0122, 0124, 0127, 0166, 0167]. ; Claim 96: wherein the method of Claim 97: wherein the method of .
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.
Claims 78-89 are rejected under 35 U.S.C. 103 as being unpatentable over KAYYEM, US Publication No. 2018/0223345 A1, submitted on the Information Disclosure Statement on 18 MAY 2023; US Patent Documents Cite No. 008, and further in view of CHONGQING, CN 111013674 A, submitted on the Information Disclosure Statement on 11 MARCH 2026, Foreign Patent Documents Cite No. 001.
An English Machine Translation has been obtained from Google Patent has been used for the basis of the rejection below.
Applicant’s invention is directed towards a device.
Regarding Claim 78, the KAYYEM reference discloses a device, abstract, Figure 1A, 23A, B, [0119], comprising:
an inlet configured to receive a sample comprising one or more analytes, [0022, 0029, 0030, 0183];
a fluidic channel in fluidic connection with said inlet and a fluidic region downstream of said inlet, said fluidic channel configured to passively or actively flow said sample from said inlet to said fluidic region upon receipt of said sample, [0039, 0183, 0194];
wherein said fluidic region comprises at least one composite electrode adjacent to and operably coupled to said fluidic region, wherein said at least one composite electrode is configured to enrich for said one or more analytes from said sample in said fluidic region, [0112, 0113, 0116, 0117, 0135].
The KAYYEM discloses the claimed invention, but is silent in regards to the functionality of the fluidic region, wherein the fluidic region is configured to concentrate said one or more analytes into said fluidic region.
The CHONGQING reference discloses a device, Figure 1, abstract, bacterial sensing chip, Claim 1, comprising:
an inlet configured to receive a sample comprising one or more analytes, Figure 1, opening round hole a for receiving air/liquid inlet, page 4 ;
a fluidic channel in fluidic connection with said inlet , Figure 1, vertical column of where opening at upper shell 1 with hole a is considered be a channel in which a fluid (air/liquid) flows, page 4; and
a fluidic region downstream of said inlet, Figure 1, page 4, said fluidic channel configured to passively or actively flow said sample from said inlet to said fluidic region upon receipt of said sample, wherein said fluidic region is configured to concentrate said one or more analytes into said fluidic region and comprises at least one composite electrode adjacent to and operably coupled to said fluidic region, Figure 1, micropore net electrode 3 with aperture and net is modified, fluid passage runs through chip…filtration of pathogenic bacterium is held back in the environment space, which reads on ‘configured to concentrate’, page 4, wherein said at least one composite electrode is configured to concentrate said one or more analytes from said sample into said fluidic region, Figure 1 and 2, micropore net electrode 3 with aperture and net is modified, page 4, Element 2 and 3 on page 3.
It would be obvious to one having ordinary skill in the art before the effective filing date to modify the KAYYEM with the functionality of the fluidic region as taught by CHONGQING to eliminate any pretreatment and making of samples and the setup of CHONGQING would aid in the rapidness, simplicity and convenience and would make it more suitable for rapid enrichment and in-situ detection in an environmental space, CHONGQING abstract.
Additional Disclosures Included are: Claim 79: wherein the device of claim 78, wherein said inlet is an access port or a sample bottle, [0007, 0008, 0022, 0194], CHONGQING Figure 1, page 4, inlet with hole a.; Claim 80: wherein the device of claim 78, wherein said device further comprises one or more reservoirs configured to contain one or more reagents, Figure 21, [0004, 0007, 0022, 0025, 0026, 0113]. ; Claim 81: wherein the device of Claim 82: wherein the device of claim 81, wherein said first location comprises a first substance specific for said first analyte and configured to facilitate generation of a first signal indicative of a presence of said first analyte, upon or subsequent to contact of said first substance with said first analyte, and wherein said second location comprises a second substance specific for said second analyte different from said first analyte and configured to facilitate generation of a second signal indicative of a presence of said second analyte, upon or subsequent to contact of said second substance with said second analyte, [0112, 0113, 0116]. ; Claim 83: wherein the device of claim 81, wherein said first location and said second location are spatially separated, [0113, 0172], Figure 23A, B.; Claim 84: wherein the device of any one of claims 82 wherein said first analyte or said second analyte comprises nucleic acid molecules, and wherein said first substance or said second substance comprises a primer, [0026, 0110, 0121, 0122, 0124, 0127, 0166].; Claim 85: wherein the device of claim 81, wherein said composite electrode comprises one or more additional locations configured to act as a positive or negative control, [0116, 0117, 0121]. ; Claim 86: wherein the device of Claim 87: wherein the device of Claim 88: wherein the device of claim 87, wherein the conductive element is conductive carbon, [0138].; and Claim 89: wherein the device of .
Claim 95 is rejected under 35 U.S.C. 103 as being unpatentable over KAYYEM, US Publication No. 2018/0223345 A1, submitted on the Information Disclosure Statement on 18 MAY 2023; US Patent Documents Cite No. 008.
Regarding Claim 95, the reference KAYYEM discloses the claimed invention, but is silent in regards to wherein said applying said electric field comprises applying at most about 50 V to concentrate said one or more analytes.
KAYYEM discloses application of an electric field to the device, [0141], and further includes a dielectric layer to facilitate electrowetting and to attenuate the voltage being used in order to prevent electrolysis in the aqueous droplet, [0149].
Since KAYYEM discloses a suggestion of a means to attenuate the voltage in the system, it would be obvious to one having ordinary skill in the art before the effective filing date to modify the application of the electric field comprises applying at most about 50 V to concentrate said one or more analytes as the voltage is a result effective variable to prevent electrolysis in the aqueous droplet, [0149], In re Antonie, 559 F.2d 618, 195 USPQ 6 (CCPA 1977) and In re Boesch, 617 F.2d 272, 205 USPQ 215 (CCPA 1980).
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 CHRISTINE T MUI whose telephone number is (571)270-3243. The examiner can normally be reached M-Th 5:30 -15:30 EST.
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CTM
/CHRISTINE T MUI/Primary Examiner, Art Unit 1797
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