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 .
DETAILED ACTION
Status of Claims
Claims 1-25 are pending. Claims 10-25 have been withdrawn as drawn to non-elected inventions. Claims 1-9 have been examined.
Election/Restriction
Applicant’s election of Group I, claims 1-9, in the reply filed on 04/10/2026 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Priority
This application, Serial No. 18/261,571 (PGPub: US2024/0076714) was filed 07/14/2023. This application is a 371 of PCT/US22/13111 filed 01/20/2022, which claims benefit of 63/140,035 filed 01/21/2021 and 63/277,796 filed 11/10/2021 and 63/291,093 filed 12/17/2021.
Information Disclosure Statements
The Information Disclosure Statement filed 07/14/2023 has been considered by the Examiner.
Claim Objections
Claim 6 is objected to because of the following informalities:
Claim 6 recites glucose twice.
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.
Claim(s) 1-9 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Wronko (US 2018/0369808, Pub Date: 12/27/2018, IDS).
Regarding claim 1, Wronko teaches throughout the publication a recessed microfluidic device (see Figure 1), comprising: a base having an upper surface and a lower surface (paragraph 0030, backing layer), the upper surface comprising at least one recessed fluid transfer channel (paragraph 0022, sheet substrate with channel walls or boundaries formed on the substrate that define fluid flow paths; Figure 1, channels 120) in fluid communication with a corresponding diagnostic chamber (Figure 1, diagnostic area 130; paragraph 0031), wherein the diagnostic chamber comprises a recessed area substantially surrounded by a raised frame (paragraphs 0026, hydrophobic material embedded on the porous substrate forms channels and hydrophobic structures; paragraph 0028, wax printed on paper substrate creates a hydrophobic boundary that defines the dimension of the channels and diagnostic area and this is interpreted as a raised frame since the presence of the wax creating a boundary forms a frame that reads on the broadly recited “raised frame” limitation given that the printed boundary will be raised even to a minimal degree relative to the paper); and diagnostic paper sized to fit within the recessed area of the diagnostic chamber (paragraph 0024), wherein the diagnostic paper includes one or more diagnostic components provided thereon (paragraph 0045)
Regarding claim 2, Wronko teaches the device comprising three recessed fluid transfer channels fluidically coupled to a common channel entry (paragraph 0031).
Regarding claim 3, Wronko teaches the device wherein the diagnostic paper is a single layer sheet of hydrophilic, porous paper (paragraph 0022).
Regarding claim 4, Wronko teaches the device wherein the diagnostic paper is filter paper or chromatography paper (paragraph 0024).
Regarding claim 5, Wronko teaches the device wherein the one or more diagnostic components are selected from reagents, dyes, probes, stabilizers, catalysts, anti- coagulants, lysing agents, nanoparticles, diluents, and combinations thereof (paragraphs 0039 and 0044).
Regarding claim 6, Wronko teaches the device wherein at least one diagnostic component is capable of selectively associating with an analyte selected from aspartate transaminase, alkaline phosphatase, alanine aminotransferase, bilirubin, albumin, total serum protein, glucose, cholesterol, creatine, sodium, calcium, gamma glutamyl transferase, direct bilirubin, indirect bilirubin, unconjugated bilirubin, and lactate dehydrogenase, glucose, , calcium, and sodium (paragraphs 0006, 0043 and 0048).
Regarding claim 7, Wronko teaches the device further comprising a filter in fluid communication with at least one fluid transfer channel, wherein the filter is spaced apart from the diagnostic paper (paragraph 0034).
Regarding claim 8, Wronko teaches the device wherein the base further comprises an extension having an upper surface on which an identifying indicator is provided (see Figure 1, extension area above the microfluidic network).
Regarding claim 9, Wronko teaches the device wherein the identifying indicator comprises a QR code or barcode (paragraph 0035).
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.
Claim(s) 1-9 are rejected under 35 U.S.C. 103 as being unpatentable over Wronko (US 2018/0369808, Pub Date: 12/27/2018, IDS) in view of Battrell et al. (WO 2013/106458, IDS)
Regarding claim 1, Wronko teaches throughout the publication a recessed microfluidic device (see Figure 1), comprising: a base having an upper surface and a lower surface (paragraph 0030, backing layer), the upper surface comprising at least one recessed fluid transfer channel (paragraph 0022, sheet substrate with channel walls or boundaries formed on the substrate that define fluid flow paths; Figure 1, channels 120) in fluid communication with a corresponding diagnostic chamber (Figure 1, diagnostic area 130; paragraph 0031), wherein the diagnostic chamber comprises an area substantially surrounded by frame (paragraphs 0026 and 0028); and diagnostic paper sized to fit within the area of the diagnostic chamber (paragraph 0024), wherein the diagnostic paper includes one or more diagnostic components provided thereon (paragraph 0045).
While Wronko does not explicitly teach that the diagnostic chamber comprises a recessed area surrounded by a raised frame, Battrell teaches throughout the publication a microfluidic reaction device (abstract and see Figure 14). More specifically, Battrell teaches that the reaction chamber 207 is formed by the raised platform and internal lateral walls forming a recess (see Figure 14 and page 41, second paragraph).
It would have been prima facie obvious to one having ordinary skill in the art at the time the invention was filed to modify the device of Wronko with a defined recess reaction chamber as taught by Battrell because it would have been desirable to ensure fluid containment within the reaction areas to preserve the integrity of the reactions being conducted (Battrell, page 41, second paragraph).
Regarding claim 2, Wronko teaches the device comprising three recessed fluid transfer channels fluidically coupled to a common channel entry (paragraph 0031).
Regarding claim 3, Wronko teaches the device wherein the diagnostic paper is a single layer sheet of hydrophilic, porous paper (paragraph 0022).
Regarding claim 4, Wronko teaches the device wherein the diagnostic paper is filter paper or chromatography paper (paragraph 0024).
Regarding claim 5, Wronko teaches the device wherein the one or more diagnostic components are selected from reagents, dyes, probes, stabilizers, catalysts, anti- coagulants, lysing agents, nanoparticles, diluents, and combinations thereof (paragraphs 0039 and 0044).
Regarding claim 6, Wronko teaches the device wherein at least one diagnostic component is capable of selectively associating with an analyte selected from aspartate transaminase, alkaline phosphatase, alanine aminotransferase, bilirubin, albumin, total serum protein, glucose, cholesterol, creatine, sodium, calcium, gamma glutamyl transferase, direct bilirubin, indirect bilirubin, unconjugated bilirubin, and lactate dehydrogenase, glucose, , calcium, and sodium (paragraphs 0006, 0043 and 0048).
Regarding claim 7, Wronko teaches the device further comprising a filter in fluid communication with at least one fluid transfer channel, wherein the filter is spaced apart from the diagnostic paper (paragraph 0034).
Regarding claim 8, Wronko teaches the device wherein the base further comprises an extension having an upper surface on which an identifying indicator is provided (see Figure 1, extension area above the microfluidic network).
Regarding claim 9, Wronko teaches the device wherein the identifying indicator comprises a QR code or barcode (paragraph 0035).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Frank (WO 2019/166279, Pub Date: 09/06/2019 – translations and citations taken from cited US2021/0046481) teaches a microfluidic device including indentations to serve as the sample containers and reaction areas (paragraphs 0023-0028).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to REBECCA M GIERE whose telephone number is (571)272-5084. The examiner can normally be reached M-F 8:30-4:30.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Bao-Thuy L Nguyen can be reached at 571-272-0824. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/REBECCA M GIERE/Primary Examiner, Art Unit 1677
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