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
Applicant’s amendments, see Page 2, Rejection Under 35 U.S.C. § 112(b), filed 07/30/2025, with respect to the rejection(s) of claim(s) 6 under 35 U.S.C. § 112(b) have been fully considered but they are not persuasive because amended claim 6 still depends on cancelled claim 5. However, the rejection has been withdrawn, and instead, a new ground(s) of objection is made below in view of the incorrect dependency.
Applicant’s arguments, see Pages 2-5, Rejections Under 35 U.S.C. § 103, filed 07/30/2025, with respect to claims 1-26 have been fully considered and are persuasive. Therefore, the rejection of said claims in Office Action of 05/01/2025 has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of newly found prior art reference(s) US 2020/0088639 A1 and US 20150177138 A1.
Response to Arguments
Applicant’s arguments with respect to claim(s) 1-26 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Abstract
The abstract of the disclosure is objected to because the phrase "two dimensional" will be read as hyphenated "two-dimensional" each time.
A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b).
Specification
The disclosure is objected to because of informalities indicated in an attached, marked-up of the specification showing tracking of changes.
Appropriate correction is required.
Drawings
The drawings are objected to because reference numeral 618 in Figures 7-8 will be read as . Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Objections
Claims 1-2, 6, 9-13, 18-19, 21, and 25-26 are objected to because of informalities indicated in an attached, marked-up copy of the claims showing tracking of changes.
Appropriate correction is required.
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 non-obviousness.
Claim(s) 1-2, 6, 9-13, 16, 18-21 and 24-26 is/are rejected under 35 U.S.C. 103 as being unpatentable over Rothberg et al. (US 2020/0088639 A1) in view of Kim et al. (US 2015/0177138 A1).
Regarding independent Claim 1, Rothberg discloses an apparatus (Figure 2-1B: element 2-100 is a system; [0238]) for determining the presence or concentration of target molecules ([0238] “independent analysis of a sample”), the apparatus comprising:
a surface defining a two-dimensional array of receptor sites (Figure 2-1B: element 2-108 is a sample well; [0240] “a plurality of pixels, each pixel 2-112 associated with its own individual sample well 2-108 … The plurality of pixels may be arranged in an array”);
a waveguide arranged to receive at least a portion of incident electromagnetic radiation ([0288] “An excitation source may be coupled to an input waveguide”; Figure 2-1B: element 2-106 is an excitation source; [0238] “excitation source 2-106 may be configured to provide excitation energy”), divide the electromagnetic radiation ([0288] “the input waveguide may be split into multiple output waveguides”) and direct a portion of the electromagnetic radiation to each one (Figure 2-1B; [0239] “waveguides to deliver excitation energy to each pixel 2-112”) of a two-dimensional array of receptor sites (Figure 2-1B: element 2-108 is a sample well; [0240] “a plurality of pixels, each pixel 2-112 associated with its own individual sample well 2-108 … The plurality of pixels may be arranged in an array”); and
a detector comprising a two-dimensional array of sensing elements (Figure 2-1B: element 2-110 is a sensor; [0240] “a plurality of pixels, each pixel 2-112 associated with its own individual … sensor 2-110. The plurality of pixels may be arranged in an array”), each sensing element arranged to receive electromagnetic radiation from a different receptor site (Figure 2-1B; [0238] “Each pixel 2-112 has … a sensor 2-110 for detecting emission energy emitted by the sample”) of the two-dimensional array of receptor sites (Figure 2-1B: element 2-108 is a sample well; [0240] “a plurality of pixels, each pixel 2-112 associated with its own individual sample well 2-108 … The plurality of pixels may be arranged in an array”), but does not specifically teach:
a spectral filter provided between the surface and the detector; and
a metallic nanostructure disposed on each receptor site of the two-dimensional array of receptor sites on the surface.
However, Rothberg, in a different embodiment – see Figure 3-2 – teaches a spectral filter (Figure 3-2: element 3-260 are filtering elements; [0260]) provided between the surface (Figure 3-2; [0257] “interface between layer 3-210 and sample well layer 3-201”) and the detector (Figure 3-2: element 3-275 is a sensor; [0256]).
Therefore, it would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the apparatus of Rothberg with the embodiment of Figure 3-2, for a spectral filter provided between the surface and the detector, because “filtering elements may be configured to reduce transmission of excitation energy to sensor 3-275 while allowing luminescence from the sample well to be collected by sensor 3-275.” (Rothberg, para 261)
Rothberg is also silent with respect to a metallic nanostructure disposed on each receptor site of the two-dimensional array of receptor sites on the surface.
However, Kim, in the same field of sensors having a nanostructure, teaches a metallic nanostructure (Figure 2D; [0133] “The nanostructure may include a substrate 110, linkers 120A formed over the substrate 110, and metallic nanoparticles 140 that are grown from metal ions bonded to the linkers 120A”) disposed on each receptor site of the two-dimensional array of receptor sites (Figure 2D; [0135] “linkers 120A bonded to the surface of the substrate 110” are interpreted to be bonded at each receptor site of a two-dimensional array of receptor sites) on the surface (Figure 2D: element 114 is a surface layer; [0134] “surface layer 114, which may be metal thin film or a transition metal including a noble metal, a metal, or a mixture thereof”).
Therefore, it would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the apparatus of Rothberg with the teachings of Kim, for a metallic nanostructure disposed on each receptor site of the two-dimensional array of receptor sites on the surface, because “Nanostructures may be fabricated in diverse sizes to suit the particular application field and may be used for highly sensitive electrical, chemical, and optical sensing.” (Kim, para 9)
Regarding Claim 2, modified Rothberg discloses the apparatus of claim 1 further comprising a radiation source (Figure 2-1B: element 2-106 is an excitation source; [0238]) operable to produce electromagnetic radiation (Figure 2-1B; [0238] “excitation source 2-106 may be configured to provide excitation energy”) and wherein the waveguide is arranged to receive at least a portion of the electromagnetic radiation ([0288] “An excitation source may be coupled to an input waveguide”) produced by the radiation source (Figure 2-1B; [0238] “excitation source 2-106 may be configured to provide excitation energy”), divide the electromagnetic radiation ([0288] “the input waveguide may be split into multiple output waveguides”) and direct a portion of the electromagnetic radiation to each receptor site (Figure 2-1B; [0239] “waveguides to deliver excitation energy to each pixel 2-112”) of the two-dimensional array of receptor sites (Figure 2-1B: element 2-108 is a sample well; [0240] “a plurality of pixels, each pixel 2-112 associated with its own individual sample well 2-108 … The plurality of pixels may be arranged in an array”).
Regarding Claim 6, modified Rothberg discloses the apparatus of claim 1, but does not specifically teach a receptor provided on each metallic nanostructure.
However, Kim, in the same field of sensors having a nanostructure, teaches a receptor (Figure 2E; [0129] “FIG. 2E shows the receptors 150”) provided on each metallic nanostructure (Figure 2E; [0129] “receptors 150 may be bonded to or coat the surfaces of the metallic nanoparticles 140”).
Therefore, it would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the apparatus of Rothberg with the teachings of Kim, for a receptor provided on each metallic nanostructure, because receptors (such as enzyme substrates, ligands, amino acids, peptides, proteins, nucleic acids, lipids, or carbohydrates) act like "molecular traps" that specifically bind only to the target analyte of interest, preventing false positives from interfering substances.
Regarding Claim 9, modified Rothberg discloses the apparatus of claim 1, the waveguide (see claim 1 rejection), the detector (see claim 1 rejection), and the surface defining the two-dimensional array of receptor sites (see claim 1 rejection), but does not specifically teach that the waveguide is disposed between the detector and the surface defining the two-dimensional array of receptor sites.
However, Rothberg, in a different embodiment – see Figure 3-2 – teaches that the waveguide (Figure 3-2: element 3-220 is a waveguide; [0256]) is disposed between the detector (Figure 3-2: element 3-275 is a sensor; [0256]) and the surface (Figure 3-2; [0257] “interface between layer 3-210 and sample well layer 3-201”) defining the two-dimensional array of receptor sites (Figure 3-2: element 3-203 is a sample well; [0256]).
Therefore, it would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the apparatus of Rothberg with the embodiment of Figure 3-2, wherein the waveguide is disposed between the detector and the surface defining the two-dimensional array of receptor sites, because the waveguide allows uniform evanescent illumination across the entire two-dimensional array, which in turn allows the detector to read thousands of receptor sites at the exact same time.
Regarding Claim 10, modified Rothberg discloses the apparatus of claim 1, but does not specifically teach that the waveguide comprises a generally planar body and wherein the surface defining the two-dimensional array of receptor sites is a surface of said body.
However, Rothberg, in a different embodiment – see Figure 3-2 – teaches that the waveguide (Figure 3-2: element 3-220 is a waveguide; [0256]) comprises a generally planar body (Figure 3-2; [0256] “waveguide 3-220 may be formed in a layer”) and wherein the surface (Figure 3-2; [0257] “interface between layer 3-210 and sample well layer 3-201”) defining the two-dimensional array of receptor sites (Figure 3-2: element 3-203 is a sample well; [0256]) is a surface of said body (Figure 3-2; [0257] “excitation energy coupling components … at the interface between layer 3-210 and sample well layer 3-201 may be provided to improve coupling of excitation energy from waveguide 3-220 to sample well 3-203”).
Therefore, it would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the apparatus of Rothberg with the embodiment of Figure 3-2, wherein the waveguide comprises a generally planar body and wherein the surface defining the two-dimensional array of receptor sites is a surface of said body, “to improve or enhance coupling of excitation energy into a sample well.” (Rothberg, para 356)
Regarding Claim 11, modified Rothberg discloses the apparatus of claim 1 wherein the waveguide comprises an integrated optics plate ([0288] “An excitation source may be coupled to an input waveguide”, wherein “coupled” is interpreted as presence of optics to effectuate coupling) arranged to receive the electromagnetic radiation output by a radiation source (Figure 2-1B: element 2-106 is an excitation source; [0238] “excitation source 2-106 may be configured to provide excitation energy”) at an input (implicit for a waveguide to have an input) and to spread out the electromagnetic radiation ([0288] “the input waveguide may be split into multiple output waveguides”) over the surface defining the two-dimensional array of receptor sites (Figure 2-1B: element 2-108 is a sample well; [0240] “a plurality of pixels, each pixel 2-112 associated with its own individual sample well 2-108 … The plurality of pixels may be arranged in an array”).
Regarding Claim 12, modified Rothberg discloses the apparatus of claim 1 wherein the waveguide ([0288] “an input waveguide”) comprises a plurality of beam splitters or optical waveguide splitters ([0281] “Waveguides may be configured to split excitation energy from a single excitation source having a higher output intensity using waveguide beam splitters”) arranged to spread the incident radiation ([0281] “to create a plurality of excitation energy beams from a single excitation source”; [0288] “the input waveguide may be split into multiple output waveguides”) over the surface defining the two-dimensional array of receptor sites (Figure 2-1B: element 2-108 is a sample well; [0240] “a plurality of pixels, each pixel 2-112 associated with its own individual sample well 2-108 … The plurality of pixels may be arranged in an array”; [0288] “each output waveguide delivers excitation energy to a row or column of sample wells”).
Regarding Claim 13, modified Rothberg discloses the apparatus of claim 1, but does not specifically teach that the waveguide comprises one or more grating structures arranged to produce an interference pattern and spread the radiation over the surface defining the two-dimensional array of receptor sites.
However, Rothberg, in a different embodiment – see Figure 4-2 – teaches that the waveguide comprises one or more grating structures (Figure 4-2; [0271] “grating coupler 4-216 and waveguide 4-220 are formed from the same layer of integrated device 4-200 and may include the same material”) arranged to produce an interference pattern (implicit for a waveguide with a grating coupler can produce an interference pattern, as known in the art) and spread the radiation (Figure 4-2; [0271] “By positioning grating coupler 4-216 within excitation source coupling region 4-201, grating coupler 4-216 may couple with the excitation energy from excitation source 4-214 and couple excitation energy to waveguide 4-220. Waveguide 4-220 is configured to propagate excitation energy to the proximity of one or more sample wells 4-222”) over the surface (Figure 4-2; [0271] “sample well 4-222 is positioned on a surface of integrated device 4-200”; [0271] “surface 4-215 of integrated device 4-200”) defining the two-dimensional array of receptor sites (Figure 4-2; [0271] “one or more sample wells 4-222”).
Therefore, it would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the apparatus of Rothberg with the embodiment of Figure 4-2, wherein the waveguide comprises one or more grating structures arranged to produce an interference pattern and spread the radiation over the surface defining the two-dimensional array of receptor sites, because waveguides are extremely thin, and coupling light directly into them is difficult, but grating couplers allow vertical, top-down light injection.
Regarding Claim 16, modified Rothberg discloses the apparatus of claim 1 further comprising a user interface (Figure 2-1B: element 2-116 is a user interface; [0243]) for receiving signals from the detector (Figure 2-1B; [0243] “user interface 2-116 may allow a user to receive feedback on the performance of the instrument and/or integrated device, such as proper alignment and/or information obtained by readout signals from the sensors”).
Regarding Claim 18, modified Rothberg discloses the apparatus of claim 1, but does not specifically teach that the spectral filter comprises a two-dimensional array of individual spectral filters, each individual spectral filter being disposed adjacent a different sensing element of the two-dimensional array of sensing elements.
However, Rothberg, in a different embodiment – see Figure 7-7 – teaches that the spectral filter (Figure 7-7: element 7-700 is a multi-wavelength filter; [0406]) comprises a two-dimensional array of individual spectral filters (Figure 7-7; [0406] “region 7-708 and region 7-709 of multi-wavelength filter 7-700”; [0406] “region 7-708 allows transmission of λ1, and region 7-709 allows transmission of λ2”), each individual spectral filter being disposed adjacent a different sensing element (Figure 7-7; [0406] “sensor 7-710 positioned in region 7-708 may detect λ1 and sensor 7-711 positioned in region 7-709 may detect λ2”) of the two-dimensional array of sensing elements (Figure 7-7: sensors 7-710 and 7-711 are interpreted to be elements of a two-dimensional array of sensors).
Therefore, it would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the apparatus of Rothberg with the embodiment of Figure 7-7, wherein the spectral filter comprises a two-dimensional array of individual spectral filters, each individual spectral filter being disposed adjacent a different sensing element of the two-dimensional array of sensing elements, because placing an individual spectral filter adjacent to different sensing elements in a two-dimensional array transforms a standard, monochrome sensor into a Multispectral Filter Array (MSFA), allowing the sensor to capture multi-dimensional data (both spatial and wavelength information) in a single exposure.
Regarding Claim 19, modified Rothberg discloses the apparatus of claim 1, but does not specifically teach that the waveguide comprises a plurality of waveguide channels formed in a body of the waveguide, each waveguide channel being arranged to direct radiation to a different discrete position of a plurality of discrete positions within the body, each such discrete position being adjacent a different sensing element of the two-dimensional array of sensing elements.
However, Rothberg, in a different embodiment – see Figure 4-5 – teaches that the waveguide (Figure 4-5: element 4-500 is a star coupler; [0289]) comprises a plurality of waveguide channels formed in a body of the waveguide (Figure 4-5; [0289] “Light of two different wavelengths may be input to the star coupler using a single waveguide or two waveguides, 4-501 and 4-502”), each waveguide channel being arranged to direct radiation to a different discrete position of a plurality of discrete positions within the body (Figure 4-5; [0289] “The size and shape of each input waveguide may be used to separately tune the spread of each of the excitation light beams to match at the output waveguides 4-504”, wherein “output waveguides 4-504” are interpreted as a plurality of discrete positions), each such discrete position being adjacent a different sensing element of the two-dimensional array of sensing elements ([0291] “the number of output waveguides is equal to the number of rows of pixels in the integrated device”, wherein “rows of pixels” are interpreted to comprise a two-dimensional array of sensors).
Therefore, it would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the apparatus of Rothberg with the embodiment of Figure 4-5, wherein the waveguide comprises a plurality of waveguide channels formed in a body of the waveguide, each waveguide channel being arranged to direct radiation to a different discrete position of a plurality of discrete positions within the body, each such discrete position being adjacent a different sensing element of the two-dimensional array of sensing elements, so that “output waveguides 4-504 have substantially equal power distribution relative to one another.” (Rothberg, para 290)
Regarding Claim 20, modified Rothberg discloses the apparatus of claim 1 wherein the waveguide comprises a plurality of waveguide channels ([0288] “the input waveguide may be split into multiple output waveguides”) and waveguide splitters ([0281] “Waveguides may be configured to split excitation energy from a single excitation source having a higher output intensity using waveguide beam splitters”).
Regarding Claim 21, modified Rothberg discloses the apparatus of claim 1, but does not specifically teach that the waveguide comprises a two-dimensional array of coupling optics, each coupling optic arranged to couple radiation out of the waveguide and towards a different receptor site of the two-dimensional array of receptor sites.
However, Rothberg, in a different embodiment – see Figure 11-11 – teaches that the waveguide comprises a two-dimensional array of coupling optics (Figure 11-11; [0610] “a refractive microlens array is shown with no gaps between individual lenses” in the lower right corner of the figure), each coupling optic arranged to couple radiation out of the waveguide and towards a different receptor site of the two-dimensional array of receptor sites ([0610] “A refractive lens array may be created in any suitable way to improve efficiency of focusing of excitation into … the sample well”).
Therefore, it would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the apparatus of Rothberg with the embodiment of Figure 11-11, wherein the waveguide comprises a two-dimensional array of coupling optics, each coupling optic arranged to couple radiation out of the waveguide and towards a different receptor site of the two-dimensional array of receptor sites, because excitation light can be better focused into sample wells.
Regarding Claim 24, modified Rothberg discloses the apparatus of claim 21, but does not specifically teach that each coupling optic comprises a mirror or a prism.
However, Rothberg, in a different embodiment – see Figure 3-1B – teaches that each coupling optic comprises a mirror or a prism (Figure 3-1B; [0244] “Components located off of the integrated device may be used to position and align the excitation source 3-106 to the integrated device. Such components may include optical components including lenses, mirrors, prisms, apertures, attenuators, and/or optical fibers”).
Therefore, it would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the apparatus of Rothberg with the embodiment of Figure 3-1B, wherein each coupling optic comprises a mirror or a prism, because using a mirror or prism as a coupling optic to extract radiation from a waveguide and direct it toward a two-dimensional receptor array provides critical control over phase matching, spatial routing, and signal efficiency.
Regarding Claim 25, modified Rothberg discloses the apparatus of claim 21 wherein each coupling optic comprises a microlens array (Figure 11-11; [0610] “a refractive microlens array is shown with no gaps between individual lenses” in the lower right corner of the figure) arranged to receive radiation that couples out of a waveguide channel and to direct said radiation as an illumination beam towards one of the receptor sites of the two-dimensional array of receptor sites ([0610] “A refractive lens array may be created in any suitable way to improve efficiency of focusing of excitation into … the sample well”).
Regarding independent Claim 26, Rothberg discloses an apparatus (Figure 2-1B: element 2-100 is a system; [0238]) for determining the presence or concentration of target molecules ([0238] “independent analysis of a sample”), the apparatus comprising:
a surface defining a two-dimensional array of receptor sites (Figure 2-1B: element 2-108 is a sample well; [0240] “a plurality of pixels, each pixel 2-112 associated with its own individual sample well 2-108 … The plurality of pixels may be arranged in an array”);
a waveguide arranged to receive at least a portion of incident electromagnetic radiation ([0288] “An excitation source may be coupled to an input waveguide”; Figure 2-1B: element 2-106 is an excitation source; [0238] “excitation source 2-106 may be configured to provide excitation energy”), divide the electromagnetic radiation ([0288] “the input waveguide may be split into multiple output waveguides”) and direct a portion of the electromagnetic radiation to each one (Figure 2-1B; [0239] “waveguides to deliver excitation energy to each pixel 2-112”) of a two-dimensional array of receptor sites (Figure 2-1B: element 2-108 is a sample well; [0240] “a plurality of pixels, each pixel 2-112 associated with its own individual sample well 2-108 … The plurality of pixels may be arranged in an array”); and
a detector comprising a two-dimensional array of sensing elements (Figure 2-1B: element 2-110 is a sensor; [0240] “a plurality of pixels, each pixel 2-112 associated with its own individual … sensor 2-110. The plurality of pixels may be arranged in an array”), each sensing element arranged to receive electromagnetic radiation from a different receptor site (Figure 2-1B; [0238] “Each pixel 2-112 has … a sensor 2-110 for detecting emission energy emitted by the sample”) of the two-dimensional array of receptor sites (Figure 2-1B: element 2-108 is a sample well; [0240] “a plurality of pixels, each pixel 2-112 associated with its own individual sample well 2-108 … The plurality of pixels may be arranged in an array”), but does not specifically teach:
a spectral filter provided between the surface and the detector;
a metallic nanostructure disposed on each receptor site of the two-dimensional array of receptor sites on the surface; and
a receptor provided on each metallic nanostructure.
However, Rothberg, in a different embodiment – see Figure 3-2 – teaches a spectral filter (Figure 3-2: element 3-260 are filtering elements; [0260]) provided between the surface (Figure 3-2; [0257] “interface between layer 3-210 and sample well layer 3-201”) and the detector (Figure 3-2: element 3-275 is a sensor; [0256]).
Therefore, it would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the apparatus of Rothberg with the embodiment of Figure 3-2, for a spectral filter provided between the surface and the detector, because “filtering elements may be configured to reduce transmission of excitation energy to sensor 3-275 while allowing luminescence from the sample well to be collected by sensor 3-275.” (Rothberg, para 261)
Rothberg is also silent with respect to a metallic nanostructure disposed on each receptor site of the two-dimensional array of receptor sites on the surface; and
a receptor provided on each metallic nanostructure.
However, Kim, in the same field of sensors having a nanostructure, teaches a metallic nanostructure (Figure 2D; [0133] “The nanostructure may include a substrate 110, linkers 120A formed over the substrate 110, and metallic nanoparticles 140 that are grown from metal ions bonded to the linkers 120A”) disposed on each receptor site of the two-dimensional array of receptor sites (Figure 2D; [0135] “linkers 120A bonded to the surface of the substrate 110” are interpreted to be bonded at each receptor site of a two-dimensional array of receptor sites) on the surface (Figure 2D: element 114 is a surface layer; [0134] “surface layer 114, which may be metal thin film or a transition metal including a noble metal, a metal, or a mixture thereof”).
Therefore, it would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the apparatus of Rothberg with the teachings of Kim, for a metallic nanostructure disposed on each receptor site of the two-dimensional array of receptor sites on the surface, because “Nanostructures may be fabricated in diverse sizes to suit the particular application field and may be used for highly sensitive electrical, chemical, and optical sensing.” (Kim, para 9)
Rothberg is also silent with respect to a receptor provided on each metallic nanostructure.
However, Kim, in the same field of sensors having a nanostructure, teaches a receptor (Figure 2E; [0129] “FIG. 2E shows the receptors 150”) provided on each metallic nanostructure (Figure 2E; [0129] “receptors 150 may be bonded to or coat the surfaces of the metallic nanoparticles 140”).
Therefore, it would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the apparatus of Rothberg with the teachings of Kim, for a receptor provided on each metallic nanostructure, because receptors (such as enzyme substrates, ligands, amino acids, peptides, proteins, nucleic acids, lipids, or carbohydrates) act like "molecular traps" that specifically bind only to the target analyte of interest, preventing false positives from interfering substances.
Claim(s) 3-4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Rothberg et al. (US 2020/0088639 A1) and Kim et al. (US 2015/0177138 A1) as applied to claim 2 above, and further in view of Durrer et al. (US 2014/0093948 A1).
Regarding Claim 3, modified Rothberg discloses the apparatus of claim 2, but does not specifically teach that the radiation source is a broadband radiation source.
However, Durrer, in the same field of analyzing biological samples, teaches that the radiation source (Figure 2: element 118 is a light emitting diode; [0009]) is a broadband radiation source ([0058] “may be a LED with a broad spectrum, e.g., with a broad frequency spectrum”).
Therefore, it would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the apparatus of Rothberg with the teachings of Durrer, wherein the radiation source is a broadband radiation source, because a broadband source allows capturing the entire absorption, reflection, or transmission spectrum in a single measurement, rapidly identifying multiple compounds at once rather than scanning through wavelengths one by one.
Regarding Claim 4, modified Rothberg discloses the apparatus of claim 2, but does not specifically teach that the radiation source comprises a white light emitting diode.
However, Durrer, in the same field of analyzing biological samples, teaches that the radiation source (Figure 2: element 118 is a light emitting diode; [0009]) comprises a white light emitting diode (Figure 2; [0126] “LED 118 may comprise at least one white LED 132”).
Therefore, it would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the apparatus of Rothberg with the teachings of Durrer, wherein the radiation source comprises a white light emitting diode, because “The use of white LEDs as disclosed in the present invention, e.g., for an illumination of biological samples and/or for measuring a presence and/or a concentration of specific molecules, may provide a solution that may be easier and/or lower cost than integrating a bunch of multiplex single color LEDs including all of their individual primary optics.” (Durrer, para 122)
Claim(s) 7 and 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Rothberg et al. (US 2020/0088639 A1) and Kim et al. (US 2015/0177138 A1) as applied to claims 1 and 2 respectively, and further in view of Kanukurthy et al. (US 2013/0169967 A1).
Regarding Claim 7, modified Rothberg discloses the apparatus of claim 1, but does not specifically teach a printed circuit board and wherein the detector is mounted on the printed circuit board.
However, Kanukurthy, in the same field of optical analyte sensors, teaches a printed circuit board (Figure 9A: element 85 is a printed circuit board; [0085] “a support 85, such as a PCB”) and wherein the detector (Figure 9A: element 84 is a detector; [0085]) is mounted on the printed circuit board (Figure 9A: element 85 is a printed circuit board; [0085] “a support 85, such as a PCB”).
Therefore, it would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the apparatus of Rothberg with the teachings of Kanukurthy, comprising a printed circuit board and wherein the detector is mounted on the printed circuit board, “so as to establish the desired angle between light source(s), detector and optical analyte sensor.” (Kanukurthy, para 81)
Regarding Claim 8, modified Rothberg discloses the apparatus of claim 2, but does not specifically teach a printed circuit board and wherein the radiation source and the detector are both mounted on the printed circuit board.
However, Kanukurthy, in the same field of optical analyte sensors, teaches a printed circuit board (Figure 9A: element 85 is a printed circuit board; [0085] “a support 85, such as a PCB”) and wherein the radiation source (Figure 9A: element 82 is a light source; [0085]) and the detector (Figure 9A: element 84 is a detector; [0085]) are both mounted on the printed circuit board (Figure 9A: element 85 is a printed circuit board; [0085] “a support 85, such as a PCB”).
Therefore, it would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the apparatus of Rothberg with the teachings of Kanukurthy, further comprising a printed circuit board and wherein the radiation source and the detector are both mounted on the printed circuit board, “so as to establish the desired angle between light source(s), detector and optical analyte sensor.” (Kanukurthy, para 81)
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Rothberg et al. (US 2020/0088639 A1) and Kim et al. (US 2015/0177138 A1) as applied to claim 1 above, and further in view of Lee et al. (US 2016/0325281 A1).
Regarding Claim 15, modified Rothberg discloses the apparatus of claim 1, but does not specifically teach one or more sensors operable to determine one or more ambient conditions.
However, Lee, in the same field of biomaterial testing, teaches one or more sensors (Figure 4: element 150 is a temperature sensor; [0053]) operable to determine one or more ambient conditions (Figure 4; [0053] “a temperature sensor 150 which senses a temperature in the housing 101”; [0063] “temperature sensor 150 may identify an environment in which the biomaterial test apparatus is placed, … and an ambient air temperature thereof”).
Therefore, it would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the apparatus of Rothberg with the teachings of Lee, further comprising one or more sensors operable to determine one or more ambient conditions, because “it is an aspect of the present invention to provide a biomaterial test apparatus and a method of controlling the same, capable of previously sensing an ambient air temperature where a biomaterial test is performed in order to determine whether to proceed with the biomaterial test.” (Lee, para 6)
Claim 17 is rejected under 35 U.S.C. 103 as being unpatentable over Rothberg et al. (US 2020/0088639 A1) and Kim et al. (US 2015/0177138 A1) as applied to claim 1 above, and further in view of Song et al. “Application of an Integrated Microchip System with Capillary Array Electrophoresis to Optimization of Enzymatic Reactions.” Analytica Chimica Acta, vol. 487, no. 1, July 2003, pp. 75–82. https://doi.org/10.1016/S0003-2670(03)00515-4.
Regarding Claim 17, modified Rothberg discloses the apparatus of claim 1, but does not specifically teach that the spectral filter has a full width at half maximum bandwidth of 10 nm or less.
However, Song, in the same field of integrated microchip systems, teaches that the spectral filter has a full width at half maximum bandwidth of 10 nm or less (Figure 1; [Section 2.3. Fluorescence detection and capillary array electrophoresis] “A narrow band pass filter (central wavelength: 656 nm, FWHM: 10 nm, Edmund Industrial Optics) was placed in front of the CMOS microchip”).
Therefore, it would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the apparatus of Rothberg with the teachings of Song, wherein the spectral filter has a full width at half maximum bandwidth of 10 nm or less, “to remove laser scattering.” (Song, Section 2.3)
Claim(s) 22-23 is/are rejected under 35 U.S.C. 103 as being unpatentable over Rothberg et al. (US 2020/0088639 A1) and Kim et al. (US 2015/0177138 A1) as applied to claim 21 above, and further in view of Emadi et al. (US 2022/0120684 A1).
Regarding Claim 22, modified Rothberg discloses the apparatus of claim 21, but does not specifically teach that each coupling optic comprises a patterned portion at an end of a waveguide channel within a body of the waveguide.
However, Emadi, in the same field of optical coupling structures, teaches that each coupling optic comprises a patterned portion at an end of a waveguide channel (Figure 8G; [0089] “optical coupling structures such as gratings 811 are formed on the waveguide integration layer 813”) within a body of the waveguide (Figure 8G: element 845 is a waveguide; [0089]).
Therefore, it would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the apparatus of Rothberg with the teachings of Emadi, wherein each coupling optic comprises a patterned portion at an end of a waveguide channel within a body of the waveguide, because out-coupling extracts confined light from the waveguide into the detection space, significantly enhancing the signal-to-noise ratio, improving detection efficiency, and allowing for multiplexed or parallel readouts.
Regarding Claim 23, modified Rothberg discloses the apparatus of claim 22, but does not specifically teach that the patterned portion at the end of the waveguide channel comprises a plurality of grooves formed on a cladding material of the waveguide channel.
However, Emadi, in the same field of optical coupling structures, teaches that the patterned portion at the end of the waveguide channel comprises a plurality of grooves formed on a cladding material of the waveguide channel (Figure 8G; [0089] “A top cladding is then formed by a nanostructure layer 835, which can be another resin layer and/or a dielectric layer, upon which nanowells 815 are imprinted”).
Therefore, it would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the apparatus of Rothberg with the teachings of Emadi, wherein the patterned portion at the end of the waveguide channel comprises a plurality of grooves formed on a cladding material of the waveguide channel, because this maximizes the overlap between the target analytes and the electromagnetic field, thereby boosting the sensitivity of the sensor.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
US-2016/0131580-A1 discloses a waveguide sensor capable of direct, real-time detection and monitoring of analytes in the vicinity of the waveguide surface without requiring the tagging or labeling of the analyte. Analytic and numerical calculations have predicted that by locally detecting either changes in the evanescent field or changes in the light coupled out of the waveguide as a result of the presence of the analyte, high detection sensitivity cab be achieved.
US-2015/0211993-A1 discloses a multiplex fiber optic biosensor including an optical fiber, a plurality of noble metal nanoparticle layers, a plurality of light sources and a light source function generator. The optical fiber includes a plurality of sensing regions which are unclad regions of the optical fiber so that the fiber core is exposed, wherein the noble metal nanoparticle layers are set in each sensing regions. The light sources emit light with different wavelengths, and the noble metal nanoparticle layers absorb the lights with different wavelengths, respectively. The light sources emit the lights in different timing sequences or different carrier frequencies, wherein when the lights propagate along the optical fiber in accordance with the different timing sequences or the different carrier frequencies, a detection unit detects particle plasmon resonance signals produced by interactions between the different noble metal nanoparticle layers and the corresponding analytes.
US-2009/0195778-A1 discloses a planar nano-spectrometer formed as a single chip that uses diffraction structures, which are combinations of numerous nano-features placed in a predetermined configuration and providing multiple functionalities such as guiding light, resonantly reflecting light at multiple wavelengths, directing light to detectors, and focusing light on the detectors. The diffraction structure can be described as a digital planar hologram that comprises an optimized combination of overlaid virtual sub-gratings, each of which is resonant to a single wavelength of light. Each device includes at least one sensor, at least one light source, and at least one digital planar hologram in an optical waveguide. The device of the present invention allows detection of small amounts of analytes in gases and liquids or on solid surfaces and can be particularly advantageous for field analysis of environmental safety in multiple locations because of its miniature size and low cost.
Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Akbar H Rizvi whose telephone number is (571) 272-5085. The examiner can normally be reached Monday - Friday, 9:30 am - 6:30 pm.
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/AKBAR H. RIZVI/
Examiner, Art Unit 2877
/TARIFUR R CHOWDHURY/Supervisory Patent Examiner, Art Unit 2877
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