DETAILED CORRESPONDENCE
Summary
This is the initial Office Action based on the Murphy, et al. application filed with the Office on 7 February 2024.
Claims 1-14 are currently pending and have been fully considered.
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Priority
The instant application is a continuation application from an International Patent Application, PCT/JP2022/028379, filed on 21 July 2022, which claims priority to a US Provisional Patent Application, 63/231,850, filed on 11 August 2021. Therefore, the instant application has an effective filing date of 11 August 2021.
Information Disclosure Statement
The information disclosure statement (IDS) submitted regarding the present application filed on 16 March 2024, is in compliance with the provisions of 37 CFR 1.97. Accordingly, the IDS has been considered by the Examiner.
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.
Claims 1-6 and 9-14 are rejected under 35 U.S.C. 103 as being unpatentable over a published paper by N. Driscoll, et al. (“Two-Dimensional Ti3C2 MXene for High-Resolution Neural Interfaces”, ACS Nano, 12(10): p. 10419-10429 + Suppl, Sept. 2018; hereinafter, “Driscoll”), submitted on an IDS by Applicant, in view of a US Patent Application Publication to Kymissis (US 2008/0283751 A1; hereinafter, “Kymissis”).
Regarding claim 1, Driscoll discloses a biosignal sensing electrode (“Using this custom approach, we demonstrate the feasibility of producing implantable, multichannel neural electrode arrays …”, last ¶, Introduction, p. 10420), comprising:
a substrate (“… the parylene substrate …”, last ¶, Fabrication of Ti3C2 MXene Neural Electrode Arrays, p. 10422);
a conductive film on the substrate and having a first face on a side thereof facing the substrate, a second face on a side thereof opposite to the substrate, and an edge connecting the first face and the second face (“Metal traces and pads (Ti/Au = 10:100 nm) were patterned using standard photolithography and liftoff processes.”, Device Fabrication and Assembly, p. 10426),
wherein the conductive film comprises particles of a layered material comprising one or plural layers, the one or plural layers being oriented parallel to a surface of the substrate (Figure 1A) and comprising a layer body represented by:
MmXn
wherein M is at least one metal of Group 3, 4, 5, 6, or 7, X is a carbon atom, a nitrogen atom, or a combination thereof, n is not less than 1 and not more than 4, and m is more than n but not more than 5 (Ti3C2, Title), and
a modifier or terminal T existing on a surface of the layer body, wherein T is at least one selected from the group consisting of a hydroxyl group, a fluorine atom, a chlorine atom, an oxygen atom, and a hydrogen atom (“… the MXenes produced for this study have a distribution of −F, −OH, and −O terminations.”, 1st ¶, Preparation and Characterization of Ti3C2 MXene, p. 10420-10421); and
a protective material comprising a polymer (“… the deposition of a top 4 μm thick parylene-C encapsulation layer …”, Device Fabrication and Assembly, p. 10426-10427) … covering at least the edge of the conductive film, the functional group being bonded to the particles of the layered material, and at least a part of the second face of the conductive film is exposed from the protective material (Figure 1A; “… lift-off to define the outline of the devices and openings over Au bonding pads and electrode contacts.”, Device Fabrication and Assembly, p. 10426-10427).
Driscoll, in teaching the encapsulation layer is parylene-C, does not teach the protective material comprising a polymer having C=O and at least one of OH and NH as a functional group.
However, Kymissis disclose a sensing device (Abstract), wherein is taught encapsulation layers that may be, among other materials, parylenes or polyvinyl alcohol ([0085]).
At the time of the filing of the present application, it would have been obvious to one of ordinary skill in the art to have made the simple substitution of one known element, i.e., polyvinyl alcohol as the encapsulant, for another known element, the Driscoll taught parylene-C encapsulation layer, with predictable results (MPEP 2143 I B).
Regarding claim 2, Driscoll does not explicitly teach wherein the polymer penetrates into the conductive film.
However, one of ordinary skill in the art would recognize that the encapsulation layer would be most effective if applied in a manner in which delamination would be prevented. Having the encapsulation layer penetrate into the MXene layer would ensure a lessor chance of delamination of the protective layer and a more robust sensing device.
Regarding claims 3 and 4, Kymissis teaches an encapsulation layer as a polymer comprises at least one selected from the group consisting of polyvinyl alcohol … ([0085]).
Regarding claim 5, Driscoll teaches the protective material further covers an outer surrounding area of the second face of the conductive film (Figure 1A).
Regarding claim 6, Driscoll teaches the outer surrounding area is a region of the second face excluding the part of the second face of the conductive film that is exposed from the protective material (Figure 1A).
Regarding claim 9, Driscoll teaches wherein the MmXn is at least one selected from the group consisting of … Ti3C2 (Title; Abstract).
Regarding claim 10, Driscoll teaches attaching the sensing probe to a steel backing (last ¶, Fabrication of Ti3C2 MXene Neural Electrode Arrays, p. 10422), resulting as the substrate is conductive.
Regarding claim 11, Driscoll teaches further comprising a lead connected to the conductive film (“… steel-backed intracortical array devices were inserted into zero-insertion force (ZIF) connectors on custom printed circuit boards for connection to the data acquisition systems for in vitro characterization or in vivo neural recording.”, Device Fabrication and Assembly, p. 10426-10427).
Regarding claim 12, Driscoll teaches wherein the surface of the substrate is in contact with the first face of the conductive film (Figure 1A).
Regarding claim 13, Driscoll teaches wherein a thickness of the conductive film is not less than 200 nm and not more than 20 μm (“The thickness of the Ti3C2 films forming the electrodes, as measured by a profilometer following lift-off patterning, is 200 ± 30 nm.”, Characterization of Ti3C2 MXene Neural Electrodes, p. 10422-10424).
Regarding claim 14, Driscoll teaches wherein the at least the part of the second face of the conductive film that is exposed from the protective material has an area of not less than 0.5 mm2 and not more than 750 mm2 (“The first electrode array is a 3 × 3 microelectrocorticography (micro-ECoG) array consisting of 50 μm × 50 μm square contacts with 300 μm pitch, covering a total recording area of 750 μm × 750 μm …”, 1st ¶, Fabrication of Ti3C2 MXene Neural Electrode Arrays, p. 10422; 750 μm × 750 μm = 562,500 μm2 = 0.5625 mm2).
Claims 7 and 8 are rejected under 35 U.S.C. 103 as being unpatentable over Driscoll in view of Kymissis as applied to claims 1-6 and 9-14 above, and further in view of a International Patent Application Publication to Ruch, et al. (WO 2020/170054 A1; hereinafter, “Ruch”).
Regarding claim 7, neither Driscoll nor Kymissis teach further comprising a cover on the second face of the conductive film, wherein a part of the second face is exposed from the cover.
However, Ruch discloses a sensor, wherein is taught lids over the sensing components in cavities (Abstract; 21, Figure 2).
At the time of the filing of the present application, it would have been obvious to one of ordinary skill in the art to have incorporated the lids taught by Ruch into the sensing device arrived at by the combination of the teachings of Driscoll and Kymissis as the lids would give a protective enclosure that could be dissolved on-demand to expose the sensor to a sensing environment (Ruch, [0032]).
Regarding claim 8, Ruch teaches wherein the protective material is between the conductive film and the cover, as the lid is placed on the rim of the cavities, with side wall material between the lid and the sensing surface (Figure 2; Abstract).
Interview with the Examiner
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The Automated Interview Request form (AIR) is available to request an interview to be scheduled with the Examiner. First, an authorization for internet communications regarding the case should be filed prior or with an AIR online request.
The internet communication authorization form (SB/0439), which authorizes or withdraws authorization for internet-based communication (e.g., video conferencing, email, etc.) for the application must be signed by the applicant or the attorney/agent for applicant. The form can be found at:
https://www.uspto.gov/sites/default/files/documents/sb0439.pdf
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https://www.uspto.gov/patent/uspto-automated-interview-request-air-form.html
The Examiner encourages, but does not require, interviews by the USPTO Microsoft Teams video conferencing. This system allows for file-sharing along audio conferencing. Microsoft Teams can be used as an internet browser add-on in Microsoft IE, Google Chrome, or Mozilla Foxfire, or as a temporary Java-based application on these browsers. Steps for joining an Examiner setup Microsoft Teams can be found at the USPTO website:
https://www.uspto.gov/patents/laws/interview-practice#step3
Additionally, a blank email to the Examiner at the time of a telephonic interview can be used for a reply to easily allow for Microsoft Teams communication. Please note, policy guidelines regarding Internet communications are detailed at MPEP §500-502.3, and office policy regarding interviews are detailed at MPEP §713.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JOHN C BALL whose telephone number is (571)270-5119. The examiner can normally be reached M - F, 9 am - 5:30 pm.
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/J. Christopher Ball/ Primary Examiner, Art Unit 1795