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 .
Election/Restrictions
Applicant’s election without traverse of Group II (CLAIMS 5-12) in the reply filed on 1/14/26 is acknowledged.
Claims 1-4 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.
Claim Objections
Claim 5 is objected to because of the following informalities: “A preparation method of a microbead” should be—A bead preparation method—or –A method of preparing a bead--, which would be more clear. Appropriate correction is required.
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.
(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.
Claim(s) 5-10 is/are rejected under 35 U.S.C. 102(a)(1) and (a)(2) as being anticipated by US 20170160272 (hereinafter “Tsao”).
As to claim 5, Applicant recites a preparation method of a microbead, comprising:
providing a semiconductor substrate,
forming a plurality of first coating layers which are spaced from each other on the semiconductor substrate, wherein each of the plurality of first coating layers comprises a first top surface far away from the semiconductor substrate and a first side surface connected to the first top surface;
forming a magnetic layer on the first top surface of each of the plurality of first coating layers, wherein the magnetic layer comprises a second top surface far from the first top surface and a second side surface connected to the second top surface;
forming a plurality of second coating layers on the semiconductor substrate, wherein each of the plurality of second coating layers comprises a top wall and a periphery, the top wall is connected to the second top surface, the periphery is connected to each of the top wall, the second side surface, and the first side surface;
each of the plurality of first coating layers, the respective one of the magnetic layer, and the respective one of the plurality of second coating layers cooperatively form one microbead;
separating each microbead from the semiconductor substrate.
[Examiner notes that figure 8 in Applicant’s specification exemplifies the claimed invention in general.]
Tsao teaches these limitations in the following disclosures.
Disclosed are microcarriers [equivalent to Applicant’s microbeads], encoded with an analog code, that include a capture agent for capturing an analyte. These microcarriers may be used, for example, in multiplexed assays in which each microcarrier includes a capture agent for capturing a specific analyte and an analog code for identification. Para. 0010.
In some embodiments, the microcarrier further comprises (d) a magnetic, substantially non-transparent layer that encloses the center portion of the substantially transparent polymer layer between the substantially non-transparent polymer layer and the center portion of the substantially transparent polymer layer, wherein the magnetic, substantially non-transparent layer is affixed to the first surface or the second surface of the substantially transparent polymer layer. In some embodiments, the microcarrier further comprises (e) a second substantially transparent polymer layer aligned with the first substantially transparent polymer layer, the second substantially transparent polymer layer having a center portion that is aligned with the center portion of the first substantially transparent polymer layer, wherein the second substantially transparent polymer layer is affixed to the second surface of the first substantially transparent polymer layer and does not extend beyond the two-dimensional shape of the first substantially transparent polymer layer; and (f) a magnetic, substantially non-transparent layer that encloses the center portion of the first substantially transparent polymer layer between the substantially non-transparent polymer layer and the center portion of the substantially transparent polymer layer, wherein the magnetic, substantially non-transparent layer is affixed between the first and the second substantially transparent polymer layers. In some embodiments, the magnetic, substantially non-transparent layer comprises nickel. In some embodiments, the two-dimensional shape of the substantially non-transparent polymer layer comprises a gear shape comprising a plurality of gear teeth, and wherein the analog code is represented by one or more aspects selected from the group consisting of the height of one or more gear teeth of the plurality, the width of one or more gear teeth of the plurality, the number of gear teeth in the plurality, and the arrangement of one or more gear teeth within the plurality… In some embodiments, the microcarrier is a substantially circular disc….In some embodiments, the microcarrier is less than about 200 μm in diameter. In some embodiments, the microcarrier is about 50 μm in diameter, or less than about 50 μm in thickness, or about 10 μm in thickness. In some embodiments, the substantially transparent polymer of the first or the second substantially transparent polymer layer comprises an epoxy-based polymer.
Para. 0012.
See also paragraph 0014 disclosing another embodiment of the microcarrier. This embodiment also shows the magnetic layer being affixed between the first and second transparent layers.
Tsao also discloses methods of making the microcarrier [equivalent to Applicant’s microbead.]
More specifically, Tsao teaches a method of making an encoded microcarrier, comprising: (a) depositing a substantially transparent polymer layer, wherein the substantially transparent polymer layer has a first surface and a second surface, the first and the second surfaces being parallel to each other; (b) depositing a magnetic, substantially non-transparent layer on the first surface of the substantially transparent polymer layer; (c) etching the magnetic, substantially non-transparent layer to remove a portion of the magnetic, substantially non-transparent layer that is deposited over a center portion of the substantially transparent polymer layer; (d) depositing a second substantially transparent polymer layer over the magnetic, substantially non-transparent layer, wherein the second substantially transparent polymer layer has a first surface and a second surface, the first and the second surfaces being parallel to each other, wherein the second surface is affixed to the magnetic, substantially non-transparent layer, and wherein the second substantially transparent polymer layer is aligned with the first substantially transparent polymer layer and has a center portion that is aligned with the center portion of the substantially transparent polymer layer; and (e) depositing a substantially non-transparent polymer layer on the first surface of the second substantially transparent polymer layer, wherein the substantially non-transparent polymer layer encloses the center portions of the first and the second substantially transparent polymer layers, and wherein the substantially non-transparent polymer layer comprises a two-dimensional shape representing an analog code. Para. 0015.
In some embodiments, the magnetic, substantially non-transparent layer is etched by wet etching. In some embodiments, the magnetic, substantially non-transparent layer comprises nickel. In some embodiments, the magnetic, substantially non-transparent layer is between about 50 nm and about 10 μm in thickness. In some embodiments, the magnetic, substantially non-transparent layer is less than about 0.1 μm in thickness. In some embodiments, the magnetic, substantially non-transparent layer comprises an asymmetry for orienting the analog code of the substantially non-transparent polymer layer. In some embodiments, the two-dimensional shape of the substantially non-transparent polymer layer is generated by lithography. In some embodiments, the two-dimensional shape of the substantially non-transparent polymer layer comprises a gear shape comprising a plurality of gear teeth, and wherein the analog code is represented by one or more aspects selected from the group consisting of the height of one or more gear teeth of the plurality, the width of one or more gear teeth of the plurality, the number of gear teeth in the plurality, and the arrangement of one or more gear teeth within the plurality…. In some embodiments, the method further comprises (f) before step (a), depositing a sacrificial layer on a substrate; (g) creating one or more column-shaped holes in the sacrificial layer using lithography; (h) depositing a third substantially transparent polymer layer in the one or more column-shaped holes in the sacrificial layer, wherein the first substantially transparent polymer layer is deposited in step (a) on top of the third substantially transparent polymer layer and the sacrificial layer; (i) after step (e), depositing using lithography one or more columns comprising the substantially transparent polymer on the first surface of the second substantially transparent polymer layer at a portion not covered by the substantially non-transparent polymer layer; (j) dissolving the sacrificial layer in a solvent; and (k) removing the substrate. In some embodiments, the method further comprises: (f) before step (a), depositing a sacrificial layer on a substrate; (g) as part of step (a), depositing the substantially transparent polymer layer on the sacrificial layer; (h) after step (e), dissolving the sacrificial layer in a solvent; and (i) removing the substrate. In some embodiments, the encoded microcarrier is a substantially circular disc… In some embodiments, the encoded microcarrier is less than about 200 μm in diameter. In some embodiments, the encoded microcarrier is about 50 μm in diameter. In some embodiments, the encoded microcarrier is less than about 50 μm in thickness. In some embodiments, the encoded microcarrier is about 10 μm in thickness. In some embodiments, the method further comprises: (f) coupling a capture agent for capturing an analyte to at least one of the first surface of the second substantially transparent polymer layer and the second surface of the first substantially transparent polymer layer in at least the center portion. Para. 0016.
In another aspect, provided is a method of making an encoded microcarrier, comprising: (a) depositing a sacrificial layer on a substrate; (b) depositing on the sacrificial layer a substantially non-transparent polymer layer having an outline, a first surface, and a second surface, the first and the second surfaces being parallel to each other, wherein the second surface is affixed to the sacrificial layer; (c) shaping by lithography the outline of the substantially non-transparent polymer layer, wherein the outline is shaped into a two-dimensional shape representing an analog code; (d) dissolving the sacrificial polymer layer in a solvent; and (e) removing the substrate. In another aspect, provided herein is a method of making an encoded microcarrier, comprising: (a) depositing a sacrificial layer on a substrate; (b) depositing a magnetic layer comprising a magnetic material on the sacrificial layer; (c) depositing on the magnetic layer a substantially non-transparent polymer layer having an outline, a first surface, and a second surface, the first and the second surfaces being parallel to each other, wherein the second surface is affixed to the magnetic layer; (d) shaping by lithography the outline of the substantially non-transparent polymer layer, wherein the outline is shaped into a two-dimensional shape representing an analog code; (e) dissolving the sacrificial polymer layer in a solvent; and (f) removing the substrate. Para. 0018.
Tsao teaches that the “microcarrier may refer to a physical substrate onto which a capture agent may be coupled. The microcarrier may take any suitable geometric form or shape. Para. 0052.
See also further discussions on methods of making the microcarriers (para. 0104-0108, and 0100-113, and 0184-0186, and 0191), wherein the methods taught by Tsao as discussed above, meet the limitations of Applicant’s claim 5 (which Examiner notes is exemplified by Fig. 8, as well as elsewhere). As to the last step in claim 5 (“separating each microbead from the semiconductor substrate”), see for example paragraph 0018 and also paragraph 0191 of Tsao disclosing the entire structure being immersed in a solvent, which dissolves sacrificial layer and releases microcarrier from the substrate.
Applicant’s claim 6 recites that the preparation method of the plurality of second coating layers comprises:
forming a photoresist on the semiconductor substrate;
covering a mask with the coding patterns on the photoresist, etching the photoresist by a photolithographic method,
and curing the photoresist to obtain the plurality of second coating layers,
wherein the photolithographic method is configured to transfer the coding patterns of the mask to the periphery.
See Tsao in paragraph 0080 disclosing use of a photoresist.
See Tsao in paragraph 0184 disclosing use of a mask in which UV light is applied through the mask, allowing segments 1212 and 1214 to pass through and treat sacrificial layer. [The mask is equivalent to the claimed protective layer.
See Tsao in paragraph 0186 disclosing an etch-block layer deposited over magnetic layer 1232, as represented by etch-blocks 1236 and 1238. Unblocked segments of magnetic layer 1232 are etched out, generating the shaped magnetic layer 1242.
See also Tsao in paragraph 0106 disclosing that to generate a planar microcarrier surface using a transparent polymer layer, the transparent polymer layer may be deposited onto a planar sacrificial layer. In some embodiments, the transparent polymer may be deposited over the sacrificial layer and the substrate such that the layer is deposited on one or more column-shaped holes or void areas. In some embodiments, another transparent polymer layer may then be deposited over the sacrificial layer, and the one or more column-shaped holes or void areas filled with the first transparent polymer layer. Para. 0106.
As to claim 7, the periphery comprises an inner area and an edge area surrounding the inner area, the edge area comprises corner portions and side portions besides the corner portions, at least one coding bit is provided on at least one of the side portions, each of the at least one coding bit is configured to engrave the coding patterns.
Tsao discloses these limitations as follows.
In some embodiments, the microcarrier further comprises (d) a magnetic, substantially non-transparent layer that encloses the center portion of the substantially transparent polymer layer between the substantially non-transparent polymer layer and the center portion of the substantially transparent polymer layer, wherein the magnetic, substantially non-transparent layer is affixed to the first surface or the second surface of the substantially transparent polymer layer. In some embodiments, the microcarrier further comprises (e) a second substantially transparent polymer layer aligned with the first substantially transparent polymer layer, the second substantially transparent polymer layer having a center portion that is aligned with the center portion of the first substantially transparent polymer layer, wherein the second substantially transparent polymer layer is affixed to the second surface of the first substantially transparent polymer layer and does not extend beyond the two-dimensional shape of the first substantially transparent polymer layer; and (f) a magnetic, substantially non-transparent layer that encloses the center portion of the first substantially transparent polymer layer between the substantially non-transparent polymer layer and the center portion of the substantially transparent polymer layer, wherein the magnetic, substantially non-transparent layer is affixed between the first and the second substantially transparent polymer layers. In some embodiments, the magnetic, substantially non-transparent layer comprises nickel. In some embodiments, the two-dimensional shape of the substantially non-transparent polymer layer comprises a gear shape comprising a plurality of gear teeth, and wherein the analog code is represented by one or more aspects selected from the group consisting of the height of one or more gear teeth of the plurality, the width of one or more gear teeth of the plurality, the number of gear teeth in the plurality, and the arrangement of one or more gear teeth within the plurality…Para. 0012. [Examiner notes that the coding patterns is provided by the gear teeth.]
As to claim 8, before forming the plurality of first coating layers, the preparation method further comprises:
forming a sacrificial layer on the semiconductor substrate, wherein the plurality of first coating layers is formed on the sacrificial layer;
after forming the plurality of second coating layers, the preparation method further comprises: placing the semiconductor substrate having the sacrificial layer and each microbead in an etching solution,
wherein the etching solution has an etching property selectivity for the sacrificial layer, and is configured to separate each microbead from the semiconductor substrate.
See Tsao in paragraph 0104 disclosing that the transparent polymer layer may be deposited on a substrate, such as a semiconductor.
See Tsao in paragraph 0105 disclosing a sacrificial layer deposited on the substrate.
See Tsao in paragraph 0106 disclosing that to generate a planar microcarrier surface using a transparent polymer layer, the transparent polymer layer may be deposited onto a planar sacrificial layer. In some embodiments, the transparent polymer may be deposited over the sacrificial layer and the substrate such that the layer is deposited on one or more column-shaped holes or void areas. In some embodiments, another transparent polymer layer may then be deposited over the sacrificial layer, and the one or more column-shaped holes or void areas filled with the first transparent polymer layer. Para. 0106.
See paragraph 0108 disclosing the following.
In some embodiments, the magnetic, substantially non-transparent layer may be etched to remove a portion of the magnetic, substantially non-transparent layer that is deposited over a center portion of the substantially transparent polymer layer. The magnetic, substantially non-transparent layer may be etched by any means known in the art. For example, in some embodiments, the magnetic, substantially non-transparent layer is etched by conventional wet etching. Exemplary dimensions, shapes, and optional asymmetries for a magnetic, substantially non-transparent layer are provided supra.
As to claim 9, forming the plurality of first coating layers comprises:
forming a photoresist on the sacrificial layer;
etching the photoresist by an exposure and development process to obtain the plurality of first coating layers.
See discussion of Tsao above regarding claim 8. In particular, it is disclosed that in some embodiments, another transparent polymer layer may then be deposited over the sacrificial layer, and the one or more column-shaped holes or void areas filled with the first transparent polymer layer. Para. 0106. Moreover, see disclosures regarding the sacrificial layer in paragraphs 0106, 0113, 0179, and wet etching in paragraph 0108, and 0115.
See Tsao in paragraph 0080 disclosing use of a photoresist.
See Tsao in paragraph 0184 disclosing use of a mask in which UV light is applied through the mask, allowing segments 1212 and 1214 to pass through and treat sacrificial layer. [The mask is equivalent to the claimed protective layer.
See Tsao in paragraph 0186 disclosing an etch-block layer deposited over magnetic layer 1232, as represented by etch-blocks 1236 and 1238. Unblocked segments of magnetic layer 1232 are etched out, generating the shaped magnetic layer 1242.
See also Tsao in paragraph 0106 disclosing that to generate a planar microcarrier surface using a transparent polymer layer, the transparent polymer layer may be deposited onto a planar sacrificial layer. In some embodiments, the transparent polymer may be deposited over the sacrificial layer and the substrate such that the layer is deposited on one or more column-shaped holes or void areas. In some embodiments, another transparent polymer layer may then be deposited over the sacrificial layer, and the one or more column-shaped holes or void areas filled with the first transparent polymer layer. Para. 0106.
As to claim 10, forming the magnetic layer comprises:
forming a magnetic material on the sacrificial layer, wherein the magnetic material covers the first top surface and the first side surface of each of the plurality of first coating layers;
forming a protective layer on the magnetic material,
wherein an orthogonal projection of the protective layer onto the plurality of first coating layers is located in the plurality of first coating layers;
removing a portion of the magnetic material not covered by the protective layer, wherein a remaining portion of the magnetic material forms the magnetic layer.
See Tsao in paragraph 0184 disclosing use of a mask in which UV light is applied through the mask, allowing segments 1212 and 1214 to pass through and treat sacrificial layer. [The mask is equivalent to the claimed protective layer.
See Tsao in paragraph 0186 disclosing an etch-block layer deposited over magnetic layer 1232, as represented by etch-blocks 1236 and 1238. Unblocked segments of magnetic layer 1232 are etched out, generating the shaped magnetic layer 1242.
See Tsao in paragraph 0106 disclosing that to generate a planar microcarrier surface using a transparent polymer layer, the transparent polymer layer may be deposited onto a planar sacrificial layer. In some embodiments, the transparent polymer may be deposited over the sacrificial layer and the substrate such that the layer is deposited on one or more column-shaped holes or void areas. In some embodiments, another transparent polymer layer may then be deposited over the sacrificial layer, and the one or more column-shaped holes or void areas filled with the first transparent polymer layer. Para. 0106.
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 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 20170160272 (hereinafter “Tsao”) in view of JP 2012096232 (hereinafter “Usuki”) (original and English translation provided).
Applicant’s claim 11 recites that the magnetic material is formed by vacuum electroplating or magnetron sputtering.
While Tsao is silent as to how the magnetic material is formed, utilizing a method such as vacuum electroplating, as shown by Usuki (see 4th page of the translated version), for forming the magnetic material requires ordinary skills as it requires routine skills in the art.
More specifically teaches magnetic carrier having a biological material on its surface is produced by a production method for a magnetic carrier in which magnetic particles are added to a layer-like coating film formation treatment by silver or a coating film formation treatment by the biological material, and the layer-like coating film formation treatment by silver is carried out by using any of a silver mirror reaction method, an electroless plating method, an electroplating method, a sputtering method, a vacuum deposition method, an ion plating method and a chemical vapor deposition method. See abstract.
Thus use of known methods for forming the Tsao magnetic materials, such as a combination of vacuum electroplating as shown by Usuzki (see abstract), would have required ordinary skills in the art since are well known means for forming magnetic materials.
Claim(s) 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 20170160272 (hereinafter “Tsao”), and US 20180306828 (hereinafter “Wei”) and further in view of US 20150038355 (hereinafter “Tan”).
As to claim 12, Tsao, discussed above, is silent as to the magnetic layer comprising a chromium layer, a first tantalum layer, an iron-nickel alloy layer, and a second tantalum layer successively stacked on the plurality of first coating layers.
However, Tsao does disclose that the magnetic layer may be made of any suitable magnetic material, such as a material with paramagnetic, ferromagnetic, or ferrimagnetic properties. Huang teaches that examples of magnetic materials include without limitation are iron, nickel….as well as alloys thereof. Para. 0084.
Thus Tsao teaches that the magnetic material can be iron-nickel alloys and suggests that any suitable magnetic material can be used. It would have been predictable by one skilled in the art that layers of magnetic material can be used since they would result in a magnetic particle (disc or any shape) that can be used in the Tsao invention. Moreover, it would have been obvious to utilize known magnetic materials suitable for performing assays on magnetic particles, as this is generally suggested by Tsao.
Wei teaches chromium as a magnetic material suitable for assays.
In particular Wei teaches in paragraph 0090 the following.
In one example, a capture assay is employed. In this assay format, one monoclonal antibody is covalently bound to a magnetic particle such as, for example, a chrome (chromium dioxide) particle. The sample is incubated with these particles to allow the immunosuppressant drug in the sample to bind to the monoclonal antibody on the magnetic particle. Subsequently, a second monoclonal antibody conjugated to an enzyme such as, for example, β-galactosidase, is incubated with the magnetic particles. After application of a magnet and washing of the magnetic particles, the amount of enzyme that is bound to the magnetic particles is measured and is directly related to the presence and/or amount of the immunosuppressant drug in the sample. In this approach substrate of the reporter enzyme is added to the final reaction container, and the enzyme activity is measured spectrophotometrically as a change in absorbance over time. Para. 0090.
Thus, Wei teaches that chromium is a known magnetic material useful for forming magnetic particles (equivalent to the Tsao magnetic microcarrier). It would have been obvious to utilize chromium as the magnetic material or layer of magnetic material in the Tsao magnetic microcarrier since Huang suggests that various suitable magnetic materials can be used, and Wei teaches that chromium is such a material.
Moreover tantalum is also such a known magnetic material as taught by Tan.
In particular Tan teaches the following in paragraph 0081.
In some embodiments, the bead is responsive to a magnetic field. The bead is magnetic, superparamagnetic, paramagnetic, or ferromagnetic. These beads can comprise a coating material, e.g., a material that is attracted to another material in a magnetic field, such as iron oxide (e.g., magnetite, maghemite), magnesium, molybdenum, lithium and tantalum.
Thus Tan teaches that tantalum can be a magnetic coating material [i.e., magnetic layer].
It would have been obvious to utilize tantalum as the magnetic material or layer of magnetic material in the Huang magnetic microcarrier since Tsao suggests that various suitable magnetic materials can be used, and Tan teaches that tantalum is such a suitable magnetic material.
Conclusion
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/Ann Montgomery/Primary Examiner, Art Unit 1678
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