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 .
Status of the Claims
Claims 8, 10-13, and 18-20 are pending. Claim 8 is amended. Claims 18-20 are newly added. Accordingly, claims 8, 10-13, and 18-20 are examined herein.
Priority
The present application, filed 07/17/2025, is an RCE of U.S. Patent Application 17/825,935, filed 05/26/2022, which claims foreign priority of KR10-2021-0067850, filed 05/26/2021.
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 (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 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 8, 10-13, and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Tang et al. (Fabrication of Au Nanoparticle Arrays on Flexible Substrate for Tunable Localized Surface Plasmon Resonance. ACS Applied Materials & Interfaces. Vol. 13, No. 7, February 2021 – Non-Final dated 08/22/2025) in view of Groves et al. (WO2018169885A1 – Non-Final dated 10/24/2024), Chen et al. (Shape Memory of Microscale and Nanoscale Imprinted Patterns on a Supramolecular Polymer Compound. Macromolecular Rapid Communications. Vol. 37, No. 23, December 2016 - Non-Final dated 08/22/2025), Ahn et al. (Large-Area Roll-to-Roll and Roll-to-Plate Nanoimprint Lithography: A Step toward High-Throughput Application of Continuous Nanoimprinting. ACS Nano, Vol. 3, No. 8, August 2009), and Lopatynskyi et al. (Au Nanostructure Arrays for Plasmonic Applications: Annealed Island Films versus Nanoimprint Lithography. Nanoscale Research Letters. Vol. 10, No. 1, March 2015).
Regarding claim 8, Tang et al. teaches plasmonic nanoparticle arrays on flexible polymer substrates for localized surface plasmon resonance (LSPR) sensing. In particular, Tang et al. states that “up to now, it has been reported that LSPR has been tuned by controlling the adjacent distance between metallic nanoparticles with flexible deformation” (Introduction, paragraph 1, page 9282). Tang et al. further teaches that “in this work, with ultrasonic treatment added in the preparation, Au nanoparticle (AuNP) arrays on silicon wafers were transferred onto the flexible shape memory polyurethane (SMPU) substrate. The SMPU provided smart flexible substrates that controlled the adjacent spacing of Au nanoparticles (AuNPs)” (Introduction, paragraph 2, page 9282). Lastly, Tang et al. states that “ it was demonstrated that the tunable LSPR was achieved by bending and uniaxial tension on SMPU” (Introduction, paragraph 2, page 9282).
Although Tang et al. teaches the following: plasmonic nanoparticle sensing architecture, nanoparticles disposed on polymer substrate, spacing-dependent optical resonance sensing, Tang et al. does not teach the following: nanoimprinted resin nanostripe pattern, analyte-mediated nanoparticle sandwich architecture, roll-to-roll fabrication, and template-defined deterministic spacing.
On the other hand, Groves et al. teaches nanoparticle sandwich diagnostic immunoassays using plasmonic coupling, stating that “in one implementation of the digital molecular assay in a dual antibody immunoassay format is described here. Dual antibody immunoassays are widely used in classic clinical assays, and standard antibody pairs for this application can be readily obtained. For detection, plasmon coupling between metal nanoparticles, which will become linked via the analyte in the sandwich immunoassay, provides a robust readout of binding of the analyte molecule to the particles. Plasmon coupling offers a great strength in that the scattering wavelength of the coupled particles can differ substantially from the individual particle scattering wavelengths, leading to distinct color changes easily discerned at the single particle level by color—even on a cell phone camera” (paragraph [0249], page 46). Lastly, Groves et al. teaches that “for the present purposes, label free detection is unnecessary and detection is achieved by the secondary metal nanoparticle as a signal enhancer” (paragraph 0249, page 46).
Chen et al. teaches nanoscale imprinting of nanoscale polymer patterns, stating that “microscopic and nanoscopic scale pattern memory has recently been reported” (Introduction, paragraph 1, page 1932). In particular, “a shape memory nanopattern was prepared by imprinting a channel (grating) pattern from a PDMS nanomold onto a SMP-ZnSt film (Figure 3)” (Results and Discussion, paragraph 4, page 1935), and “the nanopatterned SMP sample (permanent pattern) was programmed into a crosshatched pattern by forming a temporary grating pattern orthogonal to the permanent grating pattern with the PDMS nanomold using thermal nanoimprint lithography at 100 °C with a compressive stress of 1.6 MPa (Figure 3b)” (Results and Discussion, paragraph 2 page 1936).
Ahn et al. teaches continuous roll-to-roll nanoimprint lithography (R2RNL) on flexible substrates, stating that “in this work, we demonstrate large-area (4 in. wide) continuous imprinting of nanogratings by using a newly developed apparatus capable of roll-to-roll imprinting (R2RNIL) on flexible web and roll-to-plate imprinting (R2PNIL) on rigid substrate. The 300 nm line width grating patterns are continuously transferred on either glass substrate (roll-to-plate mode) or flexible plastic substrate (roll-to-roll mode) with greatly enhanced throughput” (Abstract, page 2304). Ahn et al. further explains the manufacturing scalability, stating that “a continuous roll-to-roll nanoimprint lithography (R2RNIL) technique can provide a solution for high-speed large-area nanoscale patterning with greatly improved throughput; furthermore, it can overcome the challenges faced by conventional NIL in maintaining pressure uniformity and successful demolding in large-area imprinting” (Abstract, page 2304).
Lopatynskyi et al. teaches nanoimprint-defined plasmonic nanostructure arrays with controlled interparticle spacing. Specifically, Lopatynskyi et al. explains that nanoimprint fabrication enables “in this present work, two different approaches for nanostructure fabrication were used- a method based on gold island film deposition with subsequent thermal annealing and nanoimprint lithography (NIL) technique. The most evident advantage of the latter method is an exploitation of templates with relatively large linear dimensions and sub-10-nm resolution for nanostructure preparation that makes NIL suitable for fabrication of uniformly oriented and homogeneous gold nanostructure arrays (NSA) with controlled nanoparticle size, shape, and spacing” (Background, paragraph 2, page 2). Lopatynskyi et al. further teaches geometric spacing control, stating that “samples of random and ordered gold nanoparticle arrays with different morphologies, which were fabricated using thermal annealing of vacuum-evaporated island films and nanoimprint lithography methods, exhibit differences in the maximal level of plasmonic enhancement” (Conclusions, page 7).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the plasmonic nanoparticle sensing substrate of Tang et al. by incorporating the analyte-mediated nanoparticle coupling architecture of Groves et al. in order to provide a diagnostic kit structure in which first and second nanoparticles functionalized with binding compounds interact through a target material to generate an amplified plasmonic sensing signal, while further incorporating the nanoimprinted resin pattern formation techniques of Chen et al., together with the roll-to-roll nanoimprint lithography fabrication process of Ahn et al. to produce patterned polymer substrates having nanoscale stripe or grating structures capable of defining nanoparticle placement, and additionally applying the template-defined nanoparticle spacing control principles taught by Lopatynskyi et al. to achieve controlled interparticle spacing associated with predictable plasmonic optical response. Tang et al. teaches that plasmonic sensing performance depends on the spatial arrangement, density, and separation of nanoparticles on flexible polymer substrates, thereby identifying nanoparticle positioning as a critical design parameter in plasmonic sensing platforms. A person having ordinary skill in the art (PHOSITA) would have recognized that Tang et al.’s reliance on macroscopic mechanical deformation to vary nanoparticle spacing represents only one of several known engineering approaches for achieving plasmon resonance tuning. Given the well-established need in the plasmon biosensor field for improved structural precision reproducibility, and device-to-device consistency, a skilled artisan would have been motivated to replace or supplement deformation-based spacing control with nanoscale lithographic patterning methods capable of providing deterministic and permanent nanoparticle placement. Groves et al. teaches that analyte-mediated coupling between two nanoparticles functionalized with binding compounds produces enhanced optical signals suitable for diagnostic detection systems, thereby providing a recognized diagnostic assay architecture that could be integrated with Tang et al.’s plasmonic sensing substrate to enable selective biochemical sensing functionality. Since Tang et al. already demonstrates that nanoparticle spacing modulates plasmonic response, a skilled artisan would have appreciated that incorporating Groves et al.’s sandwich-type nanoparticle interaction mechanism onto a spacing-sensitive plasmonic substrate would predictably improve detection sensitivity by combining known plasmon resonance tuning effects with known analyte-mediated signal amplification mechanisms.
Chen et al. teaches that polymer substrates, including flexible shape-memory polymer systems similar to those employed by Tang et al., can be nanoimprinted to form nanoscale grating patterns or patterned surface structures. A skilled artisan would have recognized that such nanoimprinted resin nanostructures provide a practical structural means of organizing nanoparticles into ordered arrangements, thereby offering an alternative and more controllable method of defining nanoparticle spatial distribution compared with purely mechanical deformation approaches. This would have suggested modifying Tang et al.’s flexible substrate to include patterned resin nanostructures capable of physically guiding nanoparticle placement. Anh et al. further teaches that nanoimprinted nanoscale grating structures can be fabricated on flexible polymer substrates using roll-to-roll nanoimprint lithography processes, thereby demonstrating scalable and manufacturable fabrication of patterned nanostructured surfaces. Since diagnostic sensing devices are commonly produced in large quantities and benefit from uniform nanoscale feature formation, a skilled artisan would have been motivated to adopt roll-to-roll nanoimprint processing in order to enable efficient and reproducible production of patterned plasmon sensing substrates suitable for diagnostic kit implementation. Lopatynskyi et al. further teaches that nanoimprint-defined nanoscale geometry, including periodic nanostructure pitch and feature spacing, can be used to produce ordered nanoparticle arrays having controlled interparticle separation and corresponding predictable plasmonic optical behavior. A PHOSITA would therefore have recognized that integrating nanoimprint-defined nanostructure spacing principles into Tang et al.’s plasmonic sensing substrate would provide improved spatial control of nanoparticles and more reliable tuning of plasmon coupling effects, thereby enhancing diagnostic signal reproducibility and overall sensing performance. Accordingly, a PHOSITA would have been motivated to combine these teachings in order to improve structural control of nanoparticle positioning, enhance analyte-dependent plasmonic signal amplification, and enable scalable fabrication of patterned plasmonic sensing substrates for diagnostic applications.
Lastly, a PHOSITA would have had a reasonable expectation of success in making this modification because each of the applied references operates within the same technological field of nanoparticle-based plasmonic sensing and relies on well-understood physical principles governing optical coupling between metallic nanostructures. Tang et al. establishes that plasmon resonance behavior can be tuned through modification of nanoparticle spacing and arrangement on flexible polymer substrates. Groves et al. demonstrates that analyte-mediated nanoparticle coupling produces measurable and reliable signal amplification suitable for biochemical detection systems, thereby confirming compatibility between plasmonic nanoparticle platforms and diagnostic assay architectures. Chen et al. and Ahn et al. collectively demonstrate that nanoscale patterned polymer substrates can be reproducibly fabricated using nanoimprint lithography, including high-throughput roll-to-roll processing methods capable of forming periodic nanostructures that deterministically define nanoscale feature placement. Lopatynskyi et al. further confirms that engineered nanostructure pitch and template geometry can be used to control nanoparticle spacing and resulting plasmonic optical behavior in an ordered and predictable manner. Since these fabrication approaches and plasmonic sensing mechanisms were widely understood and routinely implemented in nanosensor engineering prior to the effective filing date, a skilled artisan would reasonably have expected that integrating nanoimprint-defined spacing-control substrate structures with known nanoparticle sandwich assay configurations on flexible plasmonic sensing platforms would successfully produce a functional diagnostic kit exhibiting predictable optical detection performance and improved sensing consistency.
Regarding claims 10 and 13, Groves et al. teaches spatially separated but proximate nanoparticles coupled through an analyte molecule, stating that “for detection, plasmon coupling between metal nanoparticles, which will become linked via the analyte in the sandwich immunoassay, provides a robust readout of binding of the analyte molecule to the particles” (paragraph [0249], page 46). Groves et al. further explains that “the enhanced color change due to the second nanoparticle depends on the size of the second nanoparticle as well as the effective distance between the nanoparticles” (paragraph [0250], page 46). Lastly, Groves et al. teaches that “the interparticle separation (antibody I-analyte-antibody IT) expected in our assay will be 20-30 nm and is within the limits of the effective plasmonic coupling” (paragraph [0250], page 47). Here, these disclosures teach that the second nanoparticle is positioned at a defined distance from, yet sufficiently adjacent to, the first nanoparticle to enable plasmonic coupling and signal generation, thereby meeting the structural limitation of claim 10. With respect to the additional limitation of claim 13, Groves et al. teaches nanoscale interparticle spacing associated with effective plasmonic coupling behavior. The disclosure that the interparticle separation in the assay is expected to be within a nanoscale range (e.g., 20–30 nm) demonstrates recognition in the art that plasmonic sensing performance depends on controlled spacing between coupled nanoparticles.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to configure the first and second nanoparticles of the diagnostic kit described above, so that the nanoparticles are positioned at a defined nanoscale distance from one another, as taught by Groves et al., in order to enable plasmon coupling-based signal amplification. Groves et al. recognizes that effective optical detection in nanoparticle sandwich assays depends on maintaining sufficient proximity between nanoparticles while preserving spatial separation through analyte binding structures. A skilled artisan seeking to implement a functional plasmonic diagnostic kit would therefore have been motivated to arrange nanoparticles in an adjacent yet spaced configuration to achieve measurable spectral shifts and improved detection sensitivity. Furthermore, because Groves et al. teaches that plasmonic signal enhancement depends on the effective interparticle separation and provides an example nanoscale spacing regime associated with successful coupling, a PHOSITA would have been motivated to select an adjacent nanoparticle distance within a broader practical nanoscale range, including the claimed range, as part of routine design optimization of a known sensing parameter. Lastly, a PHOSITA would have had a reasonable expectation of success in implementing the above configuration because the relationship between nanoparticle spacing and plasmonic optical response was well understood prior to the effective filing date. Groves et al. demonstrates that nanoscale separation between coupled nanoparticles produces detectable spectral shifts suitable for diagnostic sensing, thereby establishing that maintaining adjacent yet spaced nanoparticle arrangements is a predictable design consideration in plasmonic assay development. Since adjusting interparticle distance to achieve desired coupling behavior represents routine tuning of a known result-effective variable, a skilled artisan would reasonably have expected that selecting nanoparticle spacing within a workable nanoscale range would successfully produce a functional diagnostic kit exhibiting measurable plasmonic signal amplification.
Regarding claims 11, 12, and 19, Groves et al. teaches nanoparticle morphology suitable for plasmonic coupling detection. Specifically, Groves et al. discloses that “for detection, plasmon coupling between metal nanoparticles, which will become linked via the analyte in the sandwich immunoassay, provides a robust readout of binding of the analyte molecule to the particles” (paragraph [0249], page 46), and “in this example, spherical gold nanoparticles (e.g. between 10 nm and 100 nm in diameter) can work well” (paragraph [0250], page 46). Lastly, Groves et al. teaches the use of metallic nanoparticles, including gold nanoparticles, for plasmonic diagnostic sensing. Specifically, Groves et al. states that “for the present purposes, label free detection is unnecessary and detection is achieved by the secondary metal nanoparticle as a signal enhancer” (paragraph [0250], page 46).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to configure the nanoparticles of the diagnostic kit described above, to possess a morphology and material composition suitable for effective plasmonic signal generation, as taught by Groves et al. Groves et al. recognizes that plasmon coupling behavior and resulting optical detection sensitivity depend on the physical characteristics of the nanoparticles, including their shape and metallic composition. A skilled artisan implementing a functional plasmonic diagnostic kit would therefore have been motivated to employ nanoparticle shapes known to support plasmon resonance behavior, such as spherical geometries, and to select metallic nanoparticle materials known to produce strong plasmonic optical responses. Furthermore, because Groves et al. teaches that the secondary metal nanoparticle functions as a signal enhancer in analyte-mediated coupling detection, a person of ordinary skill in the art would have been motivated to select suitable plasmonic metals, including commonly used noble metals, as part of routine design considerations to achieve reliable optical signal amplification.
Lastly, a PHOSITA would have had a reasonable expectation of success in implementing the above nanoparticle morphology and material selections because the plasmonic optical properties of metallic nanoparticles were well understood prior to the effective filing date. Groves et al. demonstrates that metallic nanoparticles having suitable geometries can produce measurable plasmon coupling effects when positioned in proximity through analyte binding structures. Since the selection of nanoparticle shape and metallic composition represents routine optimization of known parameters affecting plasmon resonance behavior, a skilled artisan would reasonably have expected that employing spherical metallic nanoparticles and selecting appropriate plasmonic metals would successfully produce a diagnostic kit capable of generating detectable optical signals.
Claim 18 is rejected under 35 U.S.C. 103 as being unpatentable over Tang et al., Groves et al., Chen et al., Ahn et al., and Lopatynskyi et al., as applied to claim 8 above, and further in view of Liu et al. (Fabricating a Silver Soft Mold on a Flexible Substrate for Roll-to-Roll Nanoimprinting. IEEE Transactions on Nanotechnology. Vol. 13, No. 1, January 2014).
With respect to the teachings of Tang et al., Groves et al., Chen et al., Ahn et al., and Lopatynskyi et al., see the discussion above, which applies equally here. These references differ from the instant claims in failing to teach or specify that the substrate comprises a transparent polyethylene terephthalate (PET) film transmitting light for absorbance measurements.
However, Liu et al. teaches the use of flexible PET optical substrates in nanoimprinted nanostructure fabrication processes. Specifically, Liu et al. states that “during the R2R-UVNIL process, the silver mold was mounted on the roller with a high back-up roller pressure of 20 kgf to achieve an effective filling ratio. The UV resin was initially coated on a PET substrate” (Results and Discussion, paragraph 1, page 83). Furthermore, Liu et al. teaches optical transmission functionality associated with the PET substrate, stating that “the UV resist was cured by UV light transmitted through the PET substrate and the silver soft mold would not influence UV curing” (Results and Discussion, paragraph 2, page 83). Lastly, Liu et al. elaborates that nanostructures fabricated on PET substrates can enhance optical transmission performance, stating that “the results of this research show that the R2R-UVNIL could effectively transfer the moth-eye nanostructures to the surface of the PET substrate for the antireflection application, by achieving a 5% transmittance increase in the visible region” (Conclusions, page 84).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize a transparent PET film substrate in the plasmonic diagnostic kit described above, in order to facilitate optical transmission-based sensing measurements. Liu et al. teaches that flexible PET substrates are suitable for nanoimprinted nanostructure fabrication and permit transmission of incident light for curing and optical performance enhancement purposes. A skilled artisan designing a plasmonic diagnostic sensing platform would have been motivated to select a transparent polymer substrate such as PET because such substrates enable efficient transmission of excitation or detection light through the sensing structure while maintaining mechanical flexibility and compatibility with scalable nanoimprint fabrication processes. Thus, selecting PET as the substrate material represents a predictable material substitution to improve optical functionality and manufacturability of the diagnostic kit. Lastly, a PHOSITA would have had a reasonable expectation of success in implementing this modification because the optical transparency and fabrication compatibility of PET substrates were well established prior to the effective filing date. Liu et al. demonstrates that nanoimprinted nanostructures can be successfully fabricated on PET substrates using roll-to-roll processing techniques while maintaining optical transmission properties that enhance device performance. Since selecting a transparent polymer substrate for optical sensing applications represents routine material selection based on known optical and mechanical characteristics, a skilled artisan would reasonably have expected that incorporating a PET film substrate into the plasmonic diagnostic kit would successfully yield a functional device capable of transmitting light for absorbance or plasmonic measurement purposes.
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over Tang et al., Groves et al., Chen et al., Ahn et al., and Lopatynskyi et al., as applied to claim 8 above, and further in view of Duffy et al. (US9482662B2).
With respect to the teachings of Tang et al., Groves et al., Chen et al., Ahn et al., and Lopatynskyi et al., see the discussion above, which applies equally here. These references differ from the instant claims in failing to teach or specify that the diagnostic kit is configured to be mounted on a microwell plate having a well structure for analysis using a microplate reader.
However, Duffy et al. teaches diagnostic assay systems in which functionalized beads or sensing components are configured for use within microwell plate formats and analyzed using plate reader instrumentation. For example, Duffy et al. states that “the bead stock was distributed into a microtiter plate giving 400,000 beads per well in 100 uL” (column 64, paragraph 3, page 65). Lastly, Duffy et al. teaches optical analysis using conventional plate-reader instrumentation, stating that “for detection of enzyme, the beads were either: a) resuspended in 20 uL of PBS containing 0.1% Tween-20, and 10 uL aliquots were loaded onto two femtoliter well arrays for detection, or; b) resuspended in 100 uL of 100 uM RGP in PBS, incubated for 1 h at room temperature, and read on a fluorescence plate reader (Infinite M200. Tecan)” (column 64, paragraph 3, page 65).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the plasmonic diagnostic kit structure resulting from the combination of Tang et al., Groves et al., Chen et al., Ahn et al., and Lopatynskyi et al. by further configuring the kit for mounting within a microwell plate format as taught by Duffy et al. in order to enable standardized high-throughput optical diagnostic analysis using conventional laboratory instrumentation. A skilled artisan developing nanoparticle-based plasmonic diagnostic platforms would have recognized that practical implementation of such sensing substrates requires integration into widely adopted assay handling systems such as microtiter plates and plate readers. Duffy et al. demonstrates that nanoparticle-functionalized assay components and bead-based sensing constructs are routinely distributed into microwell plate structures for optical detection and quantitative analysis. Incorporating such mounting capability into the plasmonic diagnostic substrate of Tang et al. would have been a predictable design choice to improve usability, throughput, and compatibility with existing diagnostic workflows. Since both references operate in the field of biochemical assay detection using nanoparticle-mediated optical readout, adapting the sensing platform for microwell plate mounting would represent a routine engineering modification directed toward facilitating standardized measurement rather than a change in underlying sensing principle.
Lastly, a PHOSITA would have had a reasonable expectation of success in making this modification because microtiter plate-based assay handling and optical detection were well-established and widely used prior to the effective filing date. Duffy et al. demonstrates that functionalized nanoparticle or bead-based assay elements can be successfully distributed into microwell arrays and optically analyzed using fluorescence plate readers while maintaining diagnostic sensitivity. The plasmonic nanoparticle sensing substrate taught by Tang et al. and further structured through nanoimprinting and spacing-control techniques in the cited references operates on similar optical detection principles involving analyte-dependent signal generation. Consequently, configuring the resulting diagnostic kit for placement within a microwell plate would have involved only routine adaptation of physical format and assay handling conditions. Since the optical sensing mechanisms, biochemical binding interactions, and analytical instrumentation were all known and compatible, a skilled artisan would have reasonably expected that mounting the plasmonic diagnostic kit within a microwell plate structure would successfully permit reliable absorbance or fluorescence-based analysis without undue experimentation.
Ultimately, for the reasons set forth above, claims 8, 10–13, and 18–20 are rejected under 35 U.S.C. 103 as being unpatentable over the cited prior art combinations. The applied prior art collectively teaches or renders obvious each of the claimed structural features of the diagnostic kit, including the plasmonic nanoparticle sensing architecture, patterned polymer substrate fabrication, controlled nanoparticle spacing, nanoparticle morphology and metallic composition, transparent optical substrate selection, and configuration for standardized microwell-plate analytical formats. It would have been obvious to a PHOSITA at the time of the invention to combine the teachings of the cited references to arrive at the claimed subject matter as a predictable use of known elements according to their established functions.
For the reasons stated above, all claims are rejected.
Response to Arguments
Applicant’s remarks filed, 11/19/2025, in response to the prior non-final Office Action have been fully considered but are not persuasive.
Applicant contends that the applied references fail to teach or suggest “a substrate printed with a resin nano pattern of a roll-to-roll nanoimprint lithography, the resin nano pattern comprising a nanostripe structure that provides controlled spacing between adjacent nanoparticles.” However, as set forth in the rejection above, the combined teachings of Chen et al. and Ahn et al. establish that nanoscale patterned polymer substrates, including grating- or stripe-type nanostructures, were known fabrication outcomes of nanoimprint lithography processes and could be formed using scalable roll-to-roll manufacturing techniques. These teachings provide explicit evidence that patterned resin nanostructures capable of defining nanoscale feature placement were known in the art.
Applicant’s argument that Tang et al. relies on mechanical deformation rather than patterned structures does not overcome the rejection. The rejection does not rely on Tang et al. alone to teach patterned spacing control. Rather, Tang et al. is relied upon for teaching plasmonic nanoparticle sensing substrates in which optical response depends on nanoparticle spacing. The additional references demonstrate alternative known techniques for achieving controlled spatial positioning of nanoparticles. Substituting one known spacing-control approach for another predictable spacing-control approach represents a routine design modification that would have been obvious to one of ordinary skill in the art seeking to improve reproducibility and manufacturability of plasmonic sensing devices.
Applicant further argues that Groves et al. relies on analyte-mediated particle-to-particle coupling rather than substrate-defined spacing. However, Groves et al. is cited for teaching the diagnostic sandwich-type nanoparticle architecture and the recognized importance of interparticle separation in plasmon coupling detection. The rejection does not require Groves et al. to teach patterned substrates. Instead, the applied combination demonstrates that the art recognized both (i) the importance of nanoparticle spacing for optical sensing performance and (ii) multiple known fabrication strategies for achieving such spacing control. The combination therefore reflects the predictable integration of known sensing architectures with known nanofabrication techniques.
Applicant also asserts that the references address different technical problems and would not have been combined. This argument is not persuasive because all applied references relate to nanoparticle-based optical sensing structures or fabrication methods for nanoscale patterned substrates. The modification proposed in the rejection is directed toward improving spatial control of sensing elements and enabling scalable fabrication of plasmonic diagnostic platforms, which are recognized engineering objectives in the field. Combining references for their known and compatible teachings does not constitute impermissible hindsight but rather reflects routine application of known design principles.
Applicant’s reliance on specific functional advantages described in the specification, including alleged “platform-to-particle coupling” or enhanced amplification mechanisms, is also unpersuasive because such functional distinctions are not recited as structural limitations in the claims. Patentability must be based on the claimed subject matter rather than on unclaimed performance characteristics or theoretical operating mechanisms.
With respect to newly added dependent claims, Applicant’s arguments regarding specific substrate materials, nanoparticle morphology, and assay format likewise do not overcome the rejection. The additional references applied in the present rejection demonstrate that transparent polymer substrates suitable for optical transmission, metallic nanoparticle morphologies used in plasmonic sensing, and microwell-plate diagnostic assay configurations were all known and routinely employed design choices prior to the effective filing date. Selecting among such known alternatives to implement the claimed diagnostic kit represents routine optimization and predictable use of prior art elements according to their established functions. Accordingly, Applicant’s arguments have been considered but are not sufficient to overcome the rejections under 35 U.S.C. 103.
Conclusion
Applicant’s amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
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/E.O./Examiner, Art Unit 1677
/BAO-THUY L NGUYEN/Supervisory Patent Examiner, Art Unit 1677 March 30, 2026
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