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 .
Response to Amendment
The amendments and remarks, filed on 6/22/2026, has been entered. The claim amendments overcome the previous 112(b) rejection of claims 4 and 12.
The amendments and remarks, filed on 6/22/2026, has been entered. The prior art rejection is modified to address the claim amendments.
Claim Status
Claims 1-8 and 10-20 are pending with claims 1-8 and 10-14 being examined and claims 15-20 are withdrawn.
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 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.
Claim(s) 1-5, 7-8, and 11-14 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Ryan et al (US 20250067674 A1; hereinafter “Ryan”; priority filed on 3/11/2021; already of record).
Regarding claim 1, Ryan teaches a multi-layered nanostructure coating comprising (Ryan; Fig. 5):
a metal layer (Ryan; Fig. 5A, 5B; para [94, 95]; the metallic material is also deposited on the substrate surface, forming a continuous layer of metallic material);
a dielectric layer disposed on the metal layer (Ryan; Fig. 5A, 5B; para [79]; The monolayer of dielectric particles can be deposited on the surface of the substrate through a process known as self-assembled monolayer formation); and
a nanostructure layer disposed on a top surface of the dielectric layer (Ryan; Fig. 4), the nanostructure layer comprising sub-micrometer nanostructures that enhance fluorescence in a nucleic acid (NA) amplification reaction based on at least one of plasmonic material of which the sub-micrometer nanostructures are made and geometric dimensions of the sub-micrometer nanostructures (Ryan; Fig. 5A, 5B; para [39, 94, 141]; Following etching, the metallic material is deposited on to the dielectric cores). Ryan teaches depositing dielectric particles onto the metallic material on the substrate surface as seen in Fig. 5. Each of the particles are coated with metallic metal which is interpreted as the sub-micrometer nanostructures based on at least one of plasmonic material. Further, the particles can have different geometric shapes as described in para [141]. The limitation “that enhance fluorescence in a nucleic acid (NA) amplification reaction” is interpreted as intended use and/or functional language. The Courts have held that the manner in which a claimed apparatus is intended to be employed does not differentiate an apparatus claim from the prior art, if the prior art apparatus teaches all of the structural limitations of the claim. See Ex parte Masham, 2 USPQ2d 1647 (BPAI 1987). A functional recitation of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. See MPEP § 2114. The multi-layered nanostructure coating disclosed by Ryan teaches all of the structural limitations of the claim and thus is configured for and capable of performing the intended use and/or function language of fluorescence enhancement in a nucleic acid (NA) amplification reaction as described in para [39].
Regarding claim 2, Ryan teaches the multi-layered nanostructure coating of claim 1, further comprising a base on which the metal layer is disposed (Ryan; Fig. 5A, 5B; para [94, 95]; the metallic material is also deposited on the substrate surface, forming a continuous layer of metallic material). The examiner interprets the substrate as the base.
Regarding claim 3, Ryan teaches the multi-layered nanostructure coating of claim 1, wherein the geometric dimensions allow for radiative coupling with fluorescent labels used in the NA amplification reaction (Ryan; para [39 140]; The shape of the nanostructures is also considered to impact the properties of the chip, and again can be tuned to impart the desired properties on the chip, i.e. LSPR at the required wavelengths). The limitation “allow for radiative coupling with fluorescent labels used in the NA amplification reaction” is interpreted as intended use and/or functional language. The Courts have held that the manner in which a claimed apparatus is intended to be employed does not differentiate an apparatus claim from the prior art, if the prior art apparatus teaches all of the structural limitations of the claim. See Ex parte Masham, 2 USPQ2d 1647 (BPAI 1987). A functional recitation of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. See MPEP § 2114. The multi-layered nanostructure coating disclosed by Ryan teaches all of the structural limitations of the claim and thus is configured for and capable of performing the intended use and/or function language of allowing for radiative coupling with fluorescent labels used in the NA amplification reaction.
Regarding claim 4, Ryan teaches the multi-layered nanostructure coating of claim 3, wherein each sub-micrometer nanostructure has similar geometric dimensions for narrowband fluorescence enhancement (Ryan; Fig. 5A, 5B). The examiner notes that the geometric shapes can be identical as depicted in Fig. 5A-B.
Regarding claim 5, Ryan teaches the multi-layered nanostructure coating of claim 3, wherein the sub-micrometer nanostructures have various geometric dimensions for broadband fluorescence enhancement (Ryan; para [62]; the chip may comprise a number of regions in which the features and properties of the nanostructures of one region differ to the features and properties of the nanostructures of a second region).
Regarding claim 7, Ryan teaches the multi-layered nanostructure coating of claim 1, wherein the plasmonic material comprises a metal or a doped semiconductor (Ryan; para [17]; A nanostructure comprises a dielectric core partially coated in a metallic plasmonic material).
Regarding claim 8, Ryan teaches an amplification reaction chamber of a gene analysis system (Ryan; Abstract; para [20, 39]; The chip may be any physical entity, for example may take the form of a slide, a dish, a lateral flow strip, a multi-well plate for example a standard multi-well plate), the amplification reaction chamber comprising: an interior surface within which a nucleic acid (NA) amplification reaction is performed (Ryan; para [39, 270]; the chips of the present invention are capable of simultaneously enhancing fluorescence from fluorophores with maximum excitation wavelengths in different spectral regions…the analyte itself comprises a fluorophore. For example the analyte may be a protein fusion or may be a nucleic acid labelled with a fluorophore, for example via amplification and incorporation of labelled probes); and a multi-layered nanostructure coating conformally applied to at least a portion of the interior surface (Ryan; Fig. 5A, 5B) and comprising sub-micrometer nanostructures that enhance fluorescence in the NA amplification reaction based on at least one of plasmonic material of which the sub- micrometer nanostructures are made and geometric dimensions of the sub-micrometer nanostructures (Ryan; Fig. 5A, 5B; para [39, 141]. Ryan teaches particles coated with metallic metal which is interpreted as the sub-micrometer nanostructures based on at least one of plasmonic material. Further, the particles can have different geometric shapes as described in para [141]. The limitation “that enhance fluorescence in a nucleic acid (NA) amplification reaction” is interpreted as intended use and/or functional language. The Courts have held that the manner in which a claimed apparatus is intended to be employed does not differentiate an apparatus claim from the prior art, if the prior art apparatus teaches all of the structural limitations of the claim. See Ex parte Masham, 2 USPQ2d 1647 (BPAI 1987). A functional recitation of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. See MPEP § 2114), wherein the multi-layered nanostructure coating comprises:
base (Ryan; Fig. 5A, 5B; para [94, 95]; substrate);
a metal layer disposed on the base (Ryan; Fig. 5A, 5B; para [94, 95]; the metallic material is also deposited on the substrate surface, forming a continuous layer of metallic material);
a dielectric layer disposed on the metal layer (Ryan; Fig. 5A, 5B; para [79]; The monolayer of dielectric particles can be deposited on the surface of the substrate through a process known as self-assembled monolayer formation); and
a nanostructure layer disposed on the dielectric layer and comprising the sub-micrometer nanostructures (Ryan; Fig. 5A, 5B; para [39, 94, 141]; Following etching, the metallic material is deposited on to the dielectric cores). Ryan teaches depositing dielectric particles onto the metallic material on the substrate surface as seen in Fig. 5. Each of the particles are coated with metallic metal which is interpreted as the sub-micrometer nanostructures based on at least one of plasmonic material. The multi-layered nanostructure coating disclosed by Ryan teaches all of the structural limitations of the claim and thus is configured for and capable of performing the intended use and/or function language of fluorescence enhancement in a nucleic acid (NA) amplification reaction as described in para [39].
Regarding claim 11, Ryan teaches the amplification reaction chamber of claim 8, wherein the geometric dimensions allow for radiative coupling with fluorescent labels used in the NA amplification reaction (Ryan; para [39 140]; The shape of the nanostructures is also considered to impact the properties of the chip, and again can be tuned to impart the desired properties on the chip, i.e. LSPR at the required wavelengths). The limitation “allow for radiative coupling with fluorescent labels used in the NA amplification reaction” is interpreted as intended use and/or functional language. The Courts have held that the manner in which a claimed apparatus is intended to be employed does not differentiate an apparatus claim from the prior art, if the prior art apparatus teaches all of the structural limitations of the claim. See Ex parte Masham, 2 USPQ2d 1647 (BPAI 1987). A functional recitation of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. See MPEP § 2114. The multi-layered nanostructure coating disclosed by Ryan teaches all of the structural limitations of the claim and thus is configured for and capable of performing the intended use and/or function language of allowing for radiative coupling with fluorescent labels used in the NA amplification reaction.
Regarding claim 12, Ryan teaches the amplification reaction chamber of claim 11, wherein the sub-micrometer nanostructures have similar geometric dimensions for narrowband fluorescence enhancement (Ryan; Fig. 5A, 5B). The examiner notes that the geometric shapes can be identical as depicted in Fig. 5A-B.
Regarding claim 13, Ryan teaches the amplification reaction chamber of claim 11, wherein the sub-micrometer nanostructures have various geometric dimensions for broadband fluorescence enhancement (Ryan; para [62]; the chip may comprise a number of regions in which the features and properties of the nanostructures of one region differ to the features and properties of the nanostructures of a second region).
Regarding claim 14, Ryan teaches the amplification reaction chamber of claim 8, wherein the plasmonic material comprises a metal or a doped semiconductor (Ryan; para [17]; A nanostructure comprises a dielectric core partially coated in a metallic plasmonic material).
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 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 6 and 10 are rejected under 35 U.S.C. 103 as being unpatentable over Ryan in view of Chou et al (US 20150253321 A1; hereinafter “Chou”; already of record).
Regarding claim 6, Ryan teaches the multi-layered nanostructure coating of claim 1, wherein the metal layer is composed of aluminum (Ryan; para [75, 95]; the metallic material is selected from the group comprising or consisting: silver, gold, copper or aluminium…the metallic material is also deposited on the substrate surface).
Ryan does not teach the dielectric layer is composed of aluminum oxide.
However, Chou teaches an analogous art of a nanosensor (Chou; Abstract) comprising a dielectric layer (Chou; Fig. 1G; para [64]; dielectric nanostructures) wherein the dielectric layer is composed of aluminum oxide (Chou; Fig. 1G; para [116, 123]; The protrusion comprises a dielectric or semiconductor material selected from the group consisting of aluminum oxide). It would have been obvious to a person of ordinary skill in the art before the effective filing date of the invention to substitute the dielectric material of Ryan to be aluminum oxide as taught by Chou as this is a known and suitable element for the dielectric material in the art. One would have a reasonable expectation of success by substituting the dielectric material of Ryan to the claimed limitation of Chou, because Chou teaches the dielectric nanostructures improve the assay’s detection sensitivity. The simple substitution of one known element for another is likely to be obvious when predictable results are achieved. See KSR International Co. v. Teleflex Inc., 550 U.S. 398, 415-421, USPQ2d 1385, 1395 – 97 (2007) (see MPEP § 2143, B).
Regarding claim 10, Ryan teaches the amplification reaction chamber of claim 8, wherein the metal layer is composed of aluminum (Ryan; para [75, 95]; the metallic material is selected from the group comprising or consisting: silver, gold, copper or aluminium…the metallic material is also deposited on the substrate surface).
Ryan does not teach the dielectric layer is composed of aluminum oxide.
However, Chou teaches an analogous art of a nanosensor (Chou; Abstract) comprising a dielectric layer (Chou; Fig. 1G; para [64]; dielectric nanostructures) wherein the dielectric layer is composed of aluminum oxide (Chou; Fig. 1G; para [116, 123]; The protrusion comprises a dielectric or semiconductor material selected from the group consisting of aluminum oxide). It would have been obvious to a person of ordinary skill in the art before the effective filing date of the invention to substitute the dielectric material of Ryan to be aluminum oxide as taught by Chou as this is a known and suitable element for the dielectric material in the art. One would have a reasonable expectation of success by substituting the dielectric material of Ryan to the claimed limitation of Chou, because Chou teaches the dielectric nanostructures improve the assay’s detection sensitivity. The simple substitution of one known element for another is likely to be obvious when predictable results are achieved. See KSR International Co. v. Teleflex Inc., 550 U.S. 398, 415-421, USPQ2d 1385, 1395 – 97 (2007) (see MPEP § 2143, B).
Response to Arguments
Applicant’s arguments filed, 6/22/2026, have been fully considered. The arguments are not found to be persuasive, and the non-persuasive arguments are addressed below.
In the Applicant’s arguments, on page 7-8, the Applicant argues that Ryan fails to teach the nanostructure layer disposed on the top surface of a dielectric layer. The Examiner respectfully disagrees. The nanostructure layer disposed on a top surface of the dielectric layer is disclosed by Ryan as depicted in Figure 4. Ryan teaches depositing dielectric particles onto the metallic material on the substrate surface as seen in Fig. 5. Each of the particles are coated with metallic metal which is interpreted as the sub-micrometer nanostructures based on at least one of plasmonic material. The Examiner notes the claim limitations states “the nanostructure layer comprising sub-micrometer nanostructures”. Thus, the polystyrene layer (interpreted as the dielectric layer) has the nanostructure layer deposited on the top surface. Ryan teaches that a metal layer can be both on the substrate and onto or on top the dielectric layer as instantly claimed [94,95].
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Austin Q Le whose telephone number is (571)272-7556. The examiner can normally be reached Monday - Friday 9am - 5pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Curtis Mayes can be reached at (571) 272-1234. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/A.Q.L./Examiner, Art Unit 1796
/REBECCA M FRITCHMAN/Primary Examiner, Art Unit 1758
