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 .
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.
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 07/05/2024 and 08/23/2024 was filed after the mailing date of the application on 07/05/2024. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
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 1, 4-8, 12-15, and 17-18 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Zheng (“Osmosis-Powered Hydrogel Microneedles for Microliters of Skin Interstitial Fluid Extraction Within Minutes”, available online April 30, 2020), herein after “Zheng”.
Regarding claim 1, Zheng teaches
“A device for transdermal electrochemical measurements (Fig. 6, Abstract), the device comprising at least one polymeric support (Fig. 1A-B) having a surface configured for contact with skin (Fig. 1A)”
“at least one array of polymeric microneedles integral with the support and projecting outward from the surface of the support configured for contact with the skin (Fig. 1A-1D)”,
“at least one porous bioelectrode (Fig. 6B) comprising at least one biologically active species immobilized on the surface of a conductive material (Glucose Oxidase, GOx, page 6, section 2.4)”,
“wherein the polymeric microneedles and at least the surface of contact of the support with the skin are formed of a biocompatible crosslinked hydrogel (page 6, section 2.4 and page 2, section 2, the patch is crosslinked by UV exposure), non-electron-conductive in the dry state and electrolyte-conductive upon contact with an aqueous fluid (page 9, section 3, first paragraph),”
“wherein the at least one porous bioelectrode is arranged in contact with the hydrogel configured to swell upon contact with the aqueous fluid is free of direct contact with the skin, and is at least partially interpenetrated by crosslinked hydrogel (Abstract, Fig. 6, Discussion)”.
Regarding claim 4, the limitations of claim 1 are taught as described above. Zheng teaches “wherein the hydrogel is free of any biologically active species other than that immobilized on the at least one porous bioelectrode (page 2, section 2, Results and Figure 1)”.
Regarding claim 5, the limitations of claim 1 are taught as described above. Zheng teaches “wherein the polymeric microneedles are not hollow (page 2, section 2.2, Results and Figure 1 shows that the microneedles are not hollow)”.
Regarding claim 6, the limitations of claim 1 are taught as described above. Zheng teaches “herein the biologically active species is an enzyme, optionally combined with a molecule that facilitates electron transfer between the enzyme and the at least one porous bioelectrode (page 2, section 2.2, page 6, section 2.4, Results and Figure 1)”.
Regarding claim 7, the limitations of claim 1 are taught as described above. Zheng teaches “wherein the at least one porous bioelectrode is formed of a nano-structured or micro-structured conductive material (page 6, section 2.4)”.
Regarding claim 8, the limitations of claim 1 are taught as described above. Zheng teaches “wherein the at least one porous bioelectrode is an enzymatic bioelectrode (page 6, section 2.4)”.
Regarding claim 12, the limitations of claim 1 are taught as described above. Zheng teaches “wherein the hydrogel is derived from the crosslinking of at least one dextran polymer modified by units chosen from acrylate, methacrylate, alkenyl, and alkynyl (page 2, section 2, Results and Figure 1)”.
Regarding claim 13, the limitations of claim 1 are taught as described above. Zheng teaches “which is a transdermal microneedle patch (Pages 6-9, Fig. 6)”.
Regarding claim 14, the limitations of claim 1 are taught as described above. Zheng teaches “further comprising an electrochemical detective device attached to the at least one porous bioelectrode via electrical connections (Pages 6-9, Fig. 6)”.
Regarding claim 17, the limitations of claim 1 are taught as described above. Zheng teaches “A method for analyzing an analyte in an interstitial fluid, the method comprising: contacting the interstitial fluid with the polymeric microneedles of claim 1 (abstract, Figure 6)”.
Regarding claim 18, the limitations of claim 1 are taught as described above. Zheng teaches “A method for detecting and/or assaying at least one analyte in an interstitial fluid, the method comprising contacting the polymeric microneedles of the device of claim 1 with the interstitial fluid under conditions that are conducive to the swelling of the constituent hydrogel of the polymeric microneedles by this fluid and to the diffusion of this fluid, by a difference in osmotic pressure and/or capillarity, as far as the at least one porous bioelectrode (abstract, Figure 6)”.
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 2-3 are rejected under 35 U.S.C. 103 as being unpatentable over Zheng in view of Liu Gui-Shi (“Microneedles for transdermal diagnostics: Recent advances and new horizons”, available online December 26, 2019), herein after “Liu Gui-Shi”.
Regarding claim 2, the limitations of claim 1 are taught as described herein. Zheng does not teach the limitation "wherein the at least one porous bioelectrode is integrated in the crosslinked hydrogel constituting the support which is in direct contact with the rear of the polymeric microneedles" but Liu Gui-Shi does in an analogous microneedle device. Li Gui-Shi teaches "wherein the at least one porous bioelectrode is integrated in the crosslinked hydrogel constituting the support which is in direct contact with the rear of the polymeric microneedles (pages 2-4, section 2.2 and Figure 2)". It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the system of Liu Gui-Shi in view of Zheng. As stated in Liu Gui-Shi, having the bioelectrodes integrated into the hydrogel "avoid(s) the need for sample transfer, which significantly shortens the turnaround time" (section 2.2, page 2).
Regarding claim 3, the limitations of claim 1 are taught as described above. Zheng does not explicitly teach "wherein the hydrogel is free of any metallic constituent and electron-conductive polymer" but Liu Gui-Shi does in an analogous microneedle device. Liu Gui-Shi teaches "wherein the hydrogel is free of any metallic constituent and electron-conductive polymer (page 2, section 2.2, and Figure 2)", It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the system of Liu Gui-Shi in Zheng. The use of a hydrogel without any metallic constituent and electron-conductive polymer allows for the system to "utilize the non-enzymatic materials as both catalysts and mediators to interact with the analytes and to shuttle electrons between the catalysts and the electrodes... which induces a potential change for pH detection" (page 4).
Claims 9-10 are rejected under 35 U.S.C. 103 as being unpatentable over Zheng in view Giroud (WO 2018115710), herein after “Giroud”.
Regarding claim 9, the limitations of claim 1 are taught as described above. Zheng does not teach the use of "wherein the hydrogel is obtained by crosslinking one or more biopolymers one or more synthetic polymers, or mixtures thereof, wherein the one or more biopolymers and the one or more synthetic polymers are optionally chemically modified to be crosslinkable" but Giroud does in claim 1, which states that a bioelectrode can have a layer of hydrogel (4) with FAD-GDH as a biopolymer mixed with synthetic polymers (3) and teaches the claimed limitation as described. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the system of Giroud in Zheng. As taught in Giroud, the use of FAD-GDH results in a peak of electrochemical response and produces predictable results of improving electrical responses (page 25, lines 14-20)
Regarding claim 10, the limitations of claim 9 are taught as described above. Zheng teaches “wherein the one or more biopolymers is at least one selected from the group consisting of a polyhydroxy acid, a polysaccharide, a protein, and a peptide (page 2, section 2, Results and Figure 1)”.
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Zheng in view of Giroud and further in view of Liu Gui-Shi.
Regarding claim 11, the limitations of claim 9 are taught as described above. Neither Zheng nor Giroud teach "wherein the one or more biopolymers is at least one selected from the group consisting of an alginate, hyaluronic acid, carboxymethylcellulose, chitosan, dextran, and a derivative therefore", but Liu Gui-Shi does in an analogous microneedle device. Liu Gui-Shi teaches "wherein the one or more biopolymers is at least one selected from the group consisting of an alginate, hyaluronic acid, carboxymethylcellulose, chitosan, dextran, and a derivative therefore (Section 5.1)". It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the biopolymers of Liu Gui-Shi in Zheng, as one of ordinary skill in the art would be able to readily determine the appropriate biopolymer for the desired protein to be identified (page 8, section 5.1).
Claim 16 is rejected under 35 U.S.C. 103 as being unpatentable over Zheng in view of Khademhosseini (WO 2022/040177), herein after “Khademhosseini”.
Regarding claim 16, the limitations of claim 1 are taught as described above. Zheng does not teach "wherein the at least one porous bioelectrode is integrated by being placed in contact with the biopolymer prior to or simultaneously with its crosslinking ", however, Khademhosseini does in an analogous biosensor device. Khademhosseini teaches "wherein the at least one porous bioelectrode is integrated by being placed in contact with the biopolymer prior to or simultaneously with its crosslinking" in p.[0052] and Figure 4B. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the system of Khademhosseini in Zheng. As taught in Khamdemhosseini, the device provides an alternative way of preparing the bioelectrode for better mechanical stability and produces predictable results of having greater mechanical stability as stated in Khademhosseini.
Conclusion
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/ABIGAIL BOCK/Examiner, Art Unit 3794
/JOANNE M RODDEN/Supervisory Patent Examiner, Art Unit 3794
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