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
There are two (2) claim sets submitted on 09 MAY 2023. The claim set considered is the claim set consisting of two (2) pages, where Claims 1-92 are ‘Canceled’ and Claims 93-106 are ‘New’.
Current pending claims are Claims 93-106 and are considered on the merits below.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 14 AUGUST 2025 was filed. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they include the following reference character(s) not mentioned in the description: Figure 14A-E, character 101; Figure 17, character 502; Figure 19, character 552; Figure 24A, character 158; Figure 24G, character 181; Figure 25A, 25B, 25C, character 83. Corrected drawing sheets in compliance with 37 CFR 1.121(d), or amendment to the specification to add the reference character(s) in the description in compliance with 37 CFR 1.121(b) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
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.
Claim 93 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.
The term “sufficient” in claim 93 is a relative term which renders the claim indefinite. The term “sufficient” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. It is unclear what ‘sufficient’ is. For examination purposes, it is interpreted by the Examiner and as long as a rate and amplitude is present, it incudes mixing.
Claim Objections
Claim 106 is objected to because of the following informalities: In line 1 of the instant claim, where it recites ‘specimen comprises,’ should be ‘specimen comprises:’. Appropriate correction is required.
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 93-95, 98 and 101-106 are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by KEATCH, WO 2018/002668, submitted on the Information Disclosure Statement on 14 AUGUST 2025; Foreign Patent Documents Cite No. B68.
Applicant’s invention is directed towards a method.
Regarding Claim 93, the KEATCH reference discloses a method, comprising: moving a liquid along a microchannel of a microchannel network of a microfluidic device by increasing or decreasing a pressure of a first gas disposed within the microchannel network and in gaseous communication with a first liquid-gas interface of the liquid, wherein the increasing or decreasing is performed by contacting a first location of an exterior surface of the microfluidic device with a first actuator, the first location overlying a volume of the first gas; and independently of the increasing or decreasing the pressure of the first gas, oscillating a pressure of a second gas disposed within the microchannel network and in gaseous communication with a second liquid-gas interface of the liquid at a rate and amplitude sufficient to induce mixing of the liquid and a reagent in contact with the liquid within the microchannel, wherein the oscillating is performed by contacting a second location of an exterior surface of the microfluidic device with a second actuator, the second location overlying a volume of the second gas.
Additional Disclosures Included are : Claim 94: wherein the method of claim 93, wherein the first and second locations are spaced apart from one another., Figure 1, page 35 line 13-22, page 56 line 1 – page 57 line 9, page 59 line 23-26. ; Claim 95: wherein the method of claim 94, comprising performing one of the steps of (i) increasing or decreasing the pressure of the first gas and (ii) oscillating the pressure of the second gas, with the respective first or second actuator without simultaneously actuating the other of the first or second actuator, page 35 line 13-22 ; Claim 98: wherein the method of claim 96, wherein the moving the first liquid-gas interface over the distance comprises moving the first liquid-gas interface continuously over the distance, page 35 line 1-5, repeated steps. ; Claim 101: wherein the method of claim 94, wherein the first gas and the second gas are the same type of gas, page 49-50, clause 41. ; Claim 102: wherein the method of claim 101, wherein the first gas and the second gas is air, page 49-50, clause 41. ; Claim 103: wherein the method of claim 102, wherein the microfluidic device comprises a sample application zone in fluid communication with the microchannel and configured to receive the liquid, Figure 1, input port 3 , wherein the liquid within the microchannel and a third gas define a proximal gas-liquid interface disposed adjacent to or at the sample application zone, the third gas being air, Figure 1, as sample moves along channel to zones 28, 30, 32, there is new interface with air, page 12 line 11-17. ; Claim 104: wherein the method of claim 94, wherein the liquid comprises a biological specimen collected from a human being, page 12 line 24-25, page 17 line 31 – page 18 line 3, page 37 line 28 – page 38 line 4, page 65 line 28 – page 66 line 3. ; Claim 105: wherein the method of claim 104, wherein the liquid comprises a mixture of a liquid buffer and the biological specimen, page 12 line 24-25, page 17 line 31 – page 18 line 3, page 37 line 28 – page 38 line 4, page 65 line 28 – page 66 line 3. ; and Claim 106: wherein the method of claim 105, wherein the biological specimen comprises, a nasal specimen, salivary specimen, throat specimen, nasopharyngeal specimen, mid turbinate specimen, urine specimen, vaginal specimen, or a combination thereof, page 17 line 31 – page 18 line 3, page 37 line 28 – page 38 line 4, page 65 line 28 – page 66 line 3.
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 96, 97, 99 and 100 are rejected under 35 U.S.C. 103 as being unpatentable over KEATCH, WO 2018/002668, submitted on the Information Disclosure Statement on 14 AUGUST 2025; Foreign Patent Documents Cite No. B68.
Regarding Claims 96 and 97, the KEATCH discloses the claimed invention, but is silent in regards to wherein the moving the liquid comprises moving the first liquid-gas interface of the liquid along the microchannel over a distance of at least about 2 mm or wherein the distance is about 12.5 mm or less.
KEATCH discloses that the assay system can be and is designed and adapted for a variety of number and type of different assays. The volume of the sample may be modified and the sizing of each channel and/or chamber may be modified and/or increased/decreased in size depending on the type of assay, number of steps and/or volume of sample being introduced into the channels, page 36 line 16 – page 37 line 2.
Since KEATCH discloses the size of the channel and/or chambers may be modified based on the type of assay, number of steps and/or volume of sample being introduced into the channels, it would be obvious to one having ordinary skill in the art before the effective filing date to modify the step of moving the first liquid-gas interface of the liquid along the microchannel over a distance of at least about 2 mm or wherein the distance is about 12.5 mm or less depending on the type of assay, number of steps and/or volume of sample being introduced into the channels, page 36 line 16 – page 37 line 2, for sufficient mixing or reaction time/distance or a specific distance to prevent evaporation or cross contamination.
Regarding Claims 99 and 100, the KEATCH discloses the claimed invention, but is silent in regards to wherein the moving the liquid comprises moving the first liquid-gas interface of the liquid along the microchannel over a distance of at least about 4 mm or wherein the distance is about 12.5 mm or less.
KEATCH discloses that the assay system can be and is designed and adapted for a variety of number and type of different assays. The volume of the sample may be modified and the sizing of each channel and/or chamber may be modified and/or increased/decreased in size depending on the type of assay, number of steps and/or volume of sample being introduced into the channels, page 36 line 16 – page 37 line 2.
Since KEATCH discloses the size of the channel and/or chambers may be modified based on the type of assay, number of steps and/or volume of sample being introduced into the channels, it would be obvious to one having ordinary skill in the art before the effective filing date to modify the step of moving the first liquid-gas interface of the liquid along the microchannel over a distance of at least about 4 mm or wherein the distance is about 12.5 mm or less depending on the type of assay, number of steps and/or volume of sample being introduced into the channels, page 36 line 16 – page 37 line 2, for sufficient mixing or reaction time/distance or a specific distance to prevent evaporation or cross contamination.
Conclusion
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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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, LYLE ALEXANDER can be reached at (571) 272-1254. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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CTM
/CHRISTINE T MUI/Primary Examiner, Art Unit 1797