DETAILED ACTION
Claims 1-15 are under examination.
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Priority
Claims 1-15 do not qualify for the earlier priority date of provisional application 63,255/446 because claims 1-15 are not supported by the provisional application. The provisional application '446 does not teach or reference a biomolecular imaging sensor that contains an image sensing element, containing a plurality of unit pixels disposed in an array on a substrate, wherein each of the plurality of unit pixels contains at least one photoelectric conversion element, the photoelectric conversion element receives an incident light to generate electrons, and a surface of the image sensing element receiving the incident light is defined as a light receiving surface; and a microstructure layer, disposed on the light receiving surface of the image sensing element and having a plurality of microstructures arranged in a specific shape repeatedly, wherein each of the plurality of microstructures corresponds to at least one unit pixel. Further, '446 is silent towards a biomolecular image sensor, comprising: an image sensing element, containing a plurality of unit pixels disposed in an array on a substrate, wherein each of the plurality of unit pixels contains at least one photoelectric conversion element, the photoelectric conversion element receives an incident light to generate electrons, and a surface of the image sensing element receiving the incident light is defined as a light receiving surface; and a microstructure layer, disposed on the light receiving surface of the image sensing element and being an array formed by a plurality of micro lenses, wherein a plurality of microstructures are formed between the plurality of micro lenses, and each of the plurality of microstructures corresponds to at least one unit pixel.
Due to claims 1-15 of the instant application not being supported by '446 , the instant application does not qualify for the earlier filing date of the provisional application 63,255/446.
Claim Objections
Claims 4, 8, 11, and 15 are objected to because of the following informalities:
Claims 4, 8, 11, and 15 includes a typo reciting “claims”, instead of “claim”.
Appropriate correction is required.
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 (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 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.
Claims 1, 3-5, and 8 are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Yagi et al., (US20020081716A1).
Regarding claim 1, Yagi teaches a biomolecular image sensor (see abstract “A semiconductor device for detecting organic molecules is provided and affords higher sensitivity and better durability with respect to synthetic treatment of organic molecule probes. In one implementation, an organic molecule detecting semiconductor device 100 has pixels (including photoelectric converters) 110 disposed on a front (first main side) 101A of a silicon substrate 101, and recesses 112 in which DNA probes 161 are fixed are formed on a rear (second main side) 101B.”), comprising:
an image sensing element (CCD solid-state imaging device; see [0038] “An organic molecule detecting semiconductor device 100 of the first embodiment is configured as a frame transfer (FT) type of CCD solid-state imaging device in which numerous pixels 110 (one shown in FIG. 1) each have a photoelectric converter.”, see figure 1),
containing a plurality of unit pixels (pixels 110; see [0038], see figure 1) disposed in an array on a substrate (wherein recess 112, which are aligned with corresponding pixels 110, are disposed in an array as shown in Fig. 7A and therefore pixels 110 are disposed on an array; see [0049] “The recesses 112 correspond to the various pixels 110.”),
wherein each of the plurality of unit pixels contains at least one photoelectric conversion element (see [0038] “An organic molecule detecting semiconductor device 100 of the first embodiment is configured as a frame transfer (FT) type of CCD solid-state imaging device in which numerous pixels 110 (one shown in FIG. 1) each have a photoelectric converter. A single pixel 110 here corresponds to a single CCD solid-state imaging element having a photoelectric converter.”),
the photoelectric conversion element receives an incident light to generate electrons (see [0045] “The organic molecule detecting semiconductor device 100 thus configured is a back side-incident CCD solid-state imaging device, and frame transfer (FT) is used as the transfer method for reading the electrons photoelectrically converted on the incident side (i.e., the rear side).”, see [0047] “Also, with the organic molecule detecting semiconductor device 100, the semiconductor (e.g., silicon) substrate 101 at the bottom of the recesses 112 includes a thin film with a thickness of about 10 to 20 μm, so short wavelength light with a large absorption coefficient is almost completely absorbed and converted into electrons in the vicinity of the incident side (i.e., the back side). Moreover, there is a reduced probability that these electrons will “disappear” through rebonding within the substrate by the time they reach the pixels (including the photoelectric converters), which would lower the sensitivity, or that the electrons produced by light incident at different places on the incident side will become admixed, which would lower the resolution.”), and
a surface of the image sensing element receiving the incident light is defined as a light receiving surface (major surface/backside 101B of the CCD solid-state imaging device; see [0039], see [0043], see [0053], see figure 1);
and a microstructure layer (see [0063] “In a step 318 a multilayer film 113 is formed so as to cover the entire rear (second main side) 101B. The multilayer film 113 is formed to double as an optical filter that transmits fluorescent light and cuts out UV rays, and also as a glass substrate on which the DNA probes 161 can be fixed.”, see [0064] “This multilayer film 113 is designed to cut out light of a specific wavelength and has, for example, a three-layer structure including a silicon oxide film at the top, an aluminum oxide film in the middle, and a magnesium oxide film at the bottom (layers not shown in the drawings). As long as the uppermost layer of this multilayer film 113 is a film to which the DNA probes 161 can be fixed (such as a silicon oxide film), there are no restrictions on the materials of the other films. Specifically, an aluminum oxide film, magnesium oxide film, titanium oxide film, or the like should be suitably laminated so as to function as a filter for cutting out light of the specified wavelength. The thicknesses of the films are determined as dictated by the wavelength of the light to be cut. The multilayer film 113 may instead comprise only two layers, or it may comprise four or more layers. FIG. 6E shows the structure of the device obtained in the steps so far.”),
disposed on the light receiving surface of the image sensing element (see [0063] “In a step 318 a multilayer film 113 is formed so as to cover the entire rear (second main side) 101B. The multilayer film 113 is formed to double as an optical filter that transmits fluorescent light and cuts out UV rays, and also as a glass substrate on which the DNA probes 161 can be fixed.”) and
having a plurality of microstructures arranged in a specific shape repeatedly (organic molecule probes, e.g., DNA probes 161; see [0005] “The latter involves spotting (“printing” or depositing) a substrate (slide glass, nylon sheet, etc.) with DNA of a specific structure extracted from natural DNA that serves as an indicator, and fixing the DNA to the substrate… With both of these methods, several types of DNA probe are generally fixed on a single chip at specific locations (the DNA probe disposition regions).”),
wherein each of the plurality of microstructures corresponds to at least one unit pixel (see [0024] “Since organic molecule probes with different molecular structures are fixed in each region (corresponding to a unit pixel), it is possible to detect a plurality of different types of target DNA with a single treatment.”).
Regarding claim 3, Yagi teaches wherein each of the microstructures is formed on the image sensor element by photolithography process or imprint lithography process (see [0005] “The former involves utilizing semiconductor photolithography to chemically synthesize a DNA probe of a specific base sequence on the surface of a substrate (glass substrate).”, see [0073] “In the first embodiment given above, the description was of an example in which the DNA probes were fixed by spotting at the bottoms of the recesses 112 (the organic molecule probe disposition regions), but the DNA probes may also be synthesized by semiconductor photolithography in these organic molecule probe disposition regions.”).
Regarding claim 4, Yagi teaches wherein each of the microstructures is provided to accommodate at least one biomolecule (see [0006] “As a result, if DNA of the specified target structure is contained in the sample, it is complementarily bound to the DNA probe of the corresponding base sequence (hybridization). After this, any remaining unnecessary sample is removed from the substrate, leaving only the complementarily bound DNA on the substrate.”, see figure 5C where the biomolecule binds to the DNA probe).
Regarding claim 5, Yagi teaches wherein the incident light is a light emitted by a fluorescent marker or a chemiluminescent marker on the biomolecule (see [0053] “The excitation light causes fluorescent light to be emitted from any fluorescent labeled DNA 172 of the specified structure remaining on the incident side (side 101B) of the organic molecule detecting semiconductor device 100.”).
Regarding claim 8, Yagi teaches a method of detecting a biomolecule, comprising: (a) providing the biomolecular image sensor according to claims 1 (see the rejection of claim 1 above);
(b) accommodating the biomolecule with a fluorescent marker or a chemiluminescent marker in each of the plurality of microstructures (see [0053] “The excitation light causes fluorescent light to be emitted from any fluorescent labeled DNA 172 of the specified structure remaining on the incident side (side 101B) of the organic molecule detecting semiconductor device 100.”).;
(c) detecting an incident light in each of the plurality of microstructures by each of the plurality of unit pixels, wherein the incident light comprises a light emitted by the fluorescent marker or the chemiluminescent marker (see [0052] - [0054], see fig. 5C);
(d) generating electrons from the incident light detected by each of the plurality of unit pixels by the photoelectric conversion element (see [0045] “The organic molecule detecting semiconductor device 100 thus configured is a back side-incident CCD solid-state imaging device, and frame transfer (FT) is used as the transfer method for reading the electrons photoelectrically converted on the incident side (i.e., the rear side). Because a back side-incident CCD solid-state imaging device has no electrodes or the like formed on the incident side, and because the pixel region (including the photoelectric converters) is the same as the transfer region, the aperture area can be greater than with other solid-state imaging devices.”);
(e) generating a voltage signal based on a number of the electrons by a readout circuit coupled to each of the plurality of unit pixels (see [0043] “As shown in this drawing, the organic molecule detecting semiconductor device 100 is an FT-type of CCD solid-state imaging device in which the light is incident on the back side, and the main side (the 101 B side, or the second main side) is divided into a photoelectric converter region 131 and an accumulator 132. With this organic molecule detecting semiconductor device 100, the optical signal obtained at the various pixels 110 in the photoelectric converter region 131 is transferred to the accumulator 132 by drive current (such as a four-phase drive current) from terminals 136, after which this signal is outputted through a horizontal reader 133 and an amplifier 134 to an output terminal 135.”, see [0071] “The portions of the front (first main side) 101A aligned with the recesses 112 disposed on the rear (second main side) 101B correspond to the photoelectric converter region 131. In the illustrated embodiment, no recesses 112 are disposed in the portion of the rear (second main side) 101B aligned with the accumulator 132. Accordingly, a signal processing circuit 180 that is electrically connected to the various circuits may be disposed in the portion of the rear (second main side) 101B aligned with the accumulator 132. Alternatively, the signal processing circuit 180 may be disposed on the front (first main side) 101A. Further, the above-mentioned numerous pads 138 may be disposed on the rear (second main side) 101B.”); and
(f) analyzing a concentration of the biomolecule based on the voltage signal (wherein DNA probes 161 with different base sequences from a DNA library are fixed at the bottoms of recesses 112, and pixels 110 are read to detect the presence of the biomolecule, e.g., DNA (target); see [0054] “The optical filter/ DNA fixing film 114 at the bottoms of the recesses 112 (the organic molecule probe disposition regions) is selected to cut out or filter out the wavelength of the excitation light, which allows the fluorescent light of the DNA (target) 172 of the specified structure to be measured. In particular, fluorescent light from the DNA (target) 172 of the specified structure can be measured during irradiation with excitation light, which means that the DNA measurement takes less time.”).
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 6-7 and 9-15 are rejected under 35 U.S.C. 103 as being unpatentable over Yagi et al., as applied to claims 1 and 4-5 and in view of Yang et al., “Micro-optics for microfluidic analytical applications.” Chemical Society reviews vol. 47,4 (2018): 1391-1458. doi:10.1039/c5cs00649j.
Regarding claim 9, Yagi teaches a biomolecular image sensor (see abstract “A semiconductor device for detecting organic molecules is provided and affords higher sensitivity and better durability with respect to synthetic treatment of organic molecule probes. In one implementation, an organic molecule detecting semiconductor device 100 has pixels (including photoelectric converters) 110 disposed on a front (first main side) 101A of a silicon substrate 101, and recesses 112 in which DNA probes 161 are fixed are formed on a rear (second main side) 101B.”), comprising:
an image sensing element (CCD solid-state imaging device; see [0038] “An organic molecule detecting semiconductor device 100 of the first embodiment is configured as a frame transfer (FT) type of CCD solid-state imaging device in which numerous pixels 110 (one shown in FIG. 1) each have a photoelectric converter.”, see figure 1),
containing a plurality of unit pixels (pixels 110; see [0038], see figure 1) disposed in an array on a substrate (wherein recess 112, which are aligned with corresponding pixels 110, are disposed in an array as shown in Fig. 7A and therefore pixels 110 are disposed on an array; see [0049] “The recesses 112 correspond to the various pixels 110.”),
wherein each of the plurality of unit pixels contains at least one photoelectric conversion element (see [0038] “An organic molecule detecting semiconductor device 100 of the first embodiment is configured as a frame transfer (FT) type of CCD solid-state imaging device in which numerous pixels 110 (one shown in FIG. 1) each have a photoelectric converter. A single pixel 110 here corresponds to a single CCD solid-state imaging element having a photoelectric converter.”),
the photoelectric conversion element receives an incident light to generate electrons (see [0045] “The organic molecule detecting semiconductor device 100 thus configured is a back side-incident CCD solid-state imaging device, and frame transfer (FT) is used as the transfer method for reading the electrons photoelectrically converted on the incident side (i.e., the rear side).”, see [0047] “Also, with the organic molecule detecting semiconductor device 100, the semiconductor (e.g., silicon) substrate 101 at the bottom of the recesses 112 includes a thin film with a thickness of about 10 to 20 μm, so short wavelength light with a large absorption coefficient is almost completely absorbed and converted into electrons in the vicinity of the incident side (i.e., the back side). Moreover, there is a reduced probability that these electrons will “disappear” through rebonding within the substrate by the time they reach the pixels (including the photoelectric converters), which would lower the sensitivity, or that the electrons produced by light incident at different places on the incident side will become admixed, which would lower the resolution.”), and
a surface of the image sensing element receiving the incident light is defined as a light receiving surface (major surface/backside 101B of the CCD solid-state imaging device; see [0039], see [0043], see [0053], see figure 1); and
a microstructure layer, disposed on the light receiving surface of the image sensing element (see [0063] “In a step 318 a multilayer film 113 is formed so as to cover the entire rear (second main side) 101B. The multilayer film 113 is formed to double as an optical filter that transmits fluorescent light and cuts out UV rays, and also as a glass substrate on which the DNA probes 161 can be fixed.”, see [0064] “see [0064] “This multilayer film 113 is designed to cut out light of a specific wavelength and has, for example, a three-layer structure including a silicon oxide film at the top, an aluminum oxide film in the middle, and a magnesium oxide film at the bottom (layers not shown in the drawings). As long as the uppermost layer of this multilayer film 113 is a film to which the DNA probes 161 can be fixed (such as a silicon oxide film), there are no restrictions on the materials of the other films. Specifically, an aluminum oxide film, magnesium oxide film, titanium oxide film, or the like should be suitably laminated so as to function as a filter for cutting out light of the specified wavelength. The thicknesses of the films are determined as dictated by the wavelength of the light to be cut. The multilayer film 113 may instead comprise only two layers, or it may comprise four or more layers. FIG. 6E shows the structure of the device obtained in the steps so far.”), wherein each of the plurality of microstructures corresponds to at least one unit pixel (see [0024] “Since organic molecule probes with different molecular structures are fixed in each region (corresponding to a unit pixel), it is possible to detect a plurality of different types of target DNA with a single treatment.”).
Yagi is silent towards an array being formed by a plurality of microlenses, wherein a plurality of microstructures are formed between the plurality of microlenses.
Yang teaches an array being formed by a plurality of microlenses (see page 1404 “Another type of solid lens has an optical axis parallel to the chip plane, introducing light from the side wall of the chip,163,164 and can be directly fabricated on-chip. These microlenses are robust, vibration resistant, and simple to arrange in an array of solid microlenses of specific focal lengths.”), wherein a plurality of microstructures are formed between the plurality of microlenses (see figure 8).
It would have been prima facia obvious, at the time of the instant application, to use the array that was formed by microlenses and microstructures being formed between the plurality of microlenses as taught by Yang with the biomolecular image sensor taught by Yagi. Yang teaches that these claimed limitations are beneficial because Yang teaches that microlenses are an important and key optical component for focusing and collimating light in a microfluidic optical detection system (see page 1404). Yang further provides motivation by teaching that microlenses improve detection by focusing the light in the channel to increase the excitation power for optical measurements (see page 1404).
Regarding claim 10, Yagi teaches wherein each of the microstructures is formed on the image sensor element by photolithography process or imprint lithography process (see [0005] “The former involves utilizing semiconductor photolithography to chemically synthesize a DNA probe of a specific base sequence on the surface of a substrate (glass substrate).”, see [0073] “In the first embodiment given above, the description was of an example in which the DNA probes were fixed by spotting at the bottoms of the recesses 112 (the organic molecule probe disposition regions), but the DNA probes may also be synthesized by semiconductor photolithography in these organic molecule probe disposition regions.”).
Regarding claim 11, Yagi teaches wherein each of the microstructures is provided to accommodate at least one biomolecule (see [0006] “As a result, if DNA of the specified target structure is contained in the sample, it is complementarily bound to the DNA probe of the corresponding base sequence (hybridization). After this, any remaining unnecessary sample is removed from the substrate, leaving only the complementarily bound DNA on the substrate.”, see figure 5C where the biomolecule binds to the DNA probe).
Regarding claim 12, Yagi teaches wherein the incident light is a light emitted by a fluorescent marker or a chemiluminescent marker on the biomolecule (see [0053] “The excitation light causes fluorescent light to be emitted from any fluorescent labeled DNA 172 of the specified structure remaining on the incident side (side 101B) of the organic molecule detecting semiconductor device 100.”).
Regarding claims 6-7 and 13-14, Yagi is silent towards using a microparticle as a carrier for the biomolecule and the carrier is accommodated in the microstructure.
Yang teaches using a microparticle as a carrier for the biomolecule (see table 1 under target sample).
Yang teaches the carrier is accommodated in the microstructure (see figure 7, see page 1411 “(a) (i) Optical image of the top view of an oxynitride photonic waveguide layer. (ii and iii) Schematic cross-sections of the waveguide structure situated before (ii) and at the bioreactor well (iii). The whole system was coated with a thin SiNx film (50 nm thickness) intended to accommodate the surface for the immobilization of biomolecules containing amino groups.”).
It would have been prima facia obvious, at the time of the instant application, a carrier such as a microparticle as taught by Yang with the biomolecular image sensor taught by Yagi. Yang teaches that these claimed limitations are beneficial because Yang teaches that microparticles are commonly used in the art of microfluidic devices (see table 1, see table 4).
Regarding claim 15, Yagi and Yang teach the biomolecule sensor of claim 9 as discussed above, further, Yagi teaches a method of detecting a biomolecule (see abstract “A semiconductor device for detecting organic molecules is provided and affords higher sensitivity and better durability with respect to synthetic treatment of organic molecule probes. In one implementation, an organic molecule detecting semiconductor device 100 has pixels (including photoelectric converters) 110 disposed on a front (first main side) 101A of a silicon substrate 101, and recesses 112 in which DNA probes 161 are fixed are formed on a rear (second main side) 101B.”), comprising:
(b) accommodating the biomolecule in a sample in each of the plurality of microstructures (see [0063] “In a step 318 a multilayer film 113 is formed so as to cover the entire rear (second main side) 101B. The multilayer film 113 is formed to double as an optical filter that transmits fluorescent light and cuts out UV rays, and also as a glass substrate on which the DNA probes 161 can be fixed.”);
(c) detecting an incident light in each of the plurality of microstructures by each of the plurality of unit pixels (see [0052] - [0054], see fig. 5C);
(d) generating electrons from the incident light detected by each of the plurality of unit pixels by the photoelectric conversion element (element (see [0045] “The organic molecule detecting semiconductor device 100 thus configured is a back side-incident CCD solid-state imaging device, and frame transfer (FT) is used as the transfer method for reading the electrons photoelectrically converted on the incident side (i.e., the rear side). Because a back side-incident CCD solid-state imaging device has no electrodes or the like formed on the incident side, and because the pixel region (including the photoelectric converters) is the same as the transfer region, the aperture area can be greater than with other solid-state imaging devices.”);
(e) generating a voltage signal based on a number of the electrons by a readout circuit coupled to each of the plurality of unit pixels (see [0043] “As shown in this drawing, the organic molecule detecting semiconductor device 100 is an FT-type of CCD solid-state imaging device in which the light is incident on the back side, and the main side (the 101 B side, or the second main side) is divided into a photoelectric converter region 131 and an accumulator 132. With this organic molecule detecting semiconductor device 100, the optical signal obtained at the various pixels 110 in the photoelectric converter region 131 is transferred to the accumulator 132 by drive current (such as a four-phase drive current) from terminals 136, after which this signal is outputted through a horizontal reader 133 and an amplifier 134 to an output terminal 135.”, see [0071] “The portions of the front (first main side) 101A aligned with the recesses 112 disposed on the rear (second main side) 101B correspond to the photoelectric converter region 131. In the illustrated embodiment, no recesses 112 are disposed in the portion of the rear (second main side) 101B aligned with the accumulator 132. Accordingly, a signal processing circuit 180 that is electrically connected to the various circuits may be disposed in the portion of the rear (second main side) 101B aligned with the accumulator 132. Alternatively, the signal processing circuit 180 may be disposed on the front (first main side) 101A. Further, the above-mentioned numerous pads 138 may be disposed on the rear (second main side) 101B.”); and
(f) analyzing a presence and/or a concentration of the biomolecule based on the voltage signal (wherein DNA probes 161 with different base sequences from a DNA library are fixed at the bottoms of recesses 112, and pixels 110 are read to detect the presence of the biomolecule, e.g., DNA (target); see [0054] “The optical filter/ DNA fixing film 114 at the bottoms of the recesses 112 (the organic molecule probe disposition regions) is selected to cut out or filter out the wavelength of the excitation light, which allows the fluorescent light of the DNA (target) 172 of the specified structure to be measured. In particular, fluorescent light from the DNA (target) 172 of the specified structure can be measured during irradiation with excitation light, which means that the DNA measurement takes less time.”); wherein,
a fluorescent marker or a chemiluminescent marker is added on the biomolecule before or after (b), and the incident light comprises a light emitted by the fluorescent marker or the chemiluminescent marker (see [0052] - [0054], see fig. 5C).
Claim 2 is rejected under 35 U.S.C. 103 as being unpatentable over Yagi et al., as applied to claim 1 above and in view of Niu et al., “Micro-Nano Processing of Active Layers in Flexible Tactile Sensors via Template Methods: A Review.” Small (Weinheim an der Bergstrasse, Germany) vol. 17,41 (2021): e2100804. doi:10.1002/smll.202100804.
Regarding claim 2, Yagi is silent towards the microstructure layer is an array formed by a plurality of inverted pyramidal or honeycomb microstructures.
Niu teaches wherein the microstructure layer is an array formed by a plurality of inverted pyramidal or honeycomb microstructures (see page 22 “Chen et al. [201] sequentially coated Ag NWs solution and PDMS on the lithographic Si template with an inverted pyramid structure array, and placed the peeled Ag NWs/PDMS film face to face with the ITO/PET electrode to form a resistive pressure sensor”, see page 9 “Under certain electrolyte conditions, a cylindrical nanopore structure array with honeycomb-shaped structure is prepared by a simple, rapid, and economical oxidation process of aluminum electrode.”, see page 12).
It would have been prima facia obvious, at the time of the instant application, to use the microstructure array shapes taught by Niu with the biomolecular image sensor taught by Yagi. Niu teaches that these claimed limitations are beneficial because Niu teaches that pyramidal shapes can allow for higher sensitivity and a faster response time (see page 3 and table 1).
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1, 3, 5, 8, 10-12, and 15 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 5, and 13 of U.S. Patent No. 17731919. Although the claims at issue are not identical, they are not patentably distinct from each other because ‘919 teaches a biomolecular image sensor that comprises an image sensing element, containing a plurality of unit pixels disposed in an array on a substrate, wherein each of the plurality of unit pixels contains at least one photoelectric conversion element, the photoelectric conversion element receives an incident light to generate electrons, and a surface of the image sensing element receiving the incident light is defined as a light receiving surface; and a microstructure layer, disposed on the light receiving surface of the image sensing element and having a plurality of microstructures arranged in a specific shape repeatedly, wherein each of the plurality of microstructures corresponds to at least one unit pixel.
Regarding instant claim 1, ‘919 teaches an image sensing element, containing a plurality of unit pixels disposed in an array on a substrate, wherein each of the plurality of unit pixels contains at least one photoelectric conversion element, the photoelectric conversion element receives an incident light to generate electrons, and a surface of the image sensing element receiving the incident light is defined as a light receiving surface; and a microstructure layer, disposed on the light receiving surface of the image sensing element and having a plurality of microstructures arranged in a specific shape repeatedly, wherein each of the plurality of microstructures corresponds to at least one unit pixel (see claim 1 of ‘919).
Regarding instant claims 3 and 10, ‘919 teaches wherein each of the microstructures is formed on the image sensor element by photolithography process or imprint lithography process (see claim 5 of ‘919).
Regarding instant claims 5 and 12, ‘919 teaches wherein the incident light is a light emitted by a fluorescent marker or a chemiluminescent marker on the biomolecule (see claim 13 of ‘919).
Regarding instant claim 8, ‘919 teaches a method of detecting a biomolecule, comprising: (a) providing the biomolecular image sensor according to claims 1; (b) accommodating the biomolecule with a fluorescent marker or a chemiluminescent marker in each of the plurality of microstructures; (c) detecting an incident light in each of the plurality of microstructures by each of the plurality of unit pixels, wherein the incident light comprises a light emitted by the fluorescent marker or the chemiluminescent marker;(d) generating electrons from the incident light detected by each of the plurality of unit pixels by the photoelectric conversion element; (e) generating a voltage signal based on a number of the electrons by a readout circuit coupled to each of the plurality of unit pixels; and (f) analyzing a concentration of the biomolecule based on the voltage signal (see claims 1, 5, and 13 of ‘919).
Regarding instant claim 11, ‘919 teaches wherein each of the microstructures is provided to accommodate at least one biomolecule (see claim 1 of ‘919).
Regarding instant claim 15, ‘919 teaches a method of detecting a biomolecule, comprising:(a) providing the biomolecular image sensor according to claims 9; (b) accommodating the biomolecule in a sample in each of the plurality of microstructures; (c) detecting an incident light in each of the plurality of microstructures by each of the plurality of unit pixels; (d) generating electrons from the incident light detected by each of the plurality of unit pixels by the photoelectric conversion element; (e) generating a voltage signal based on a number of the electrons by a readout circuit coupled to each of the plurality of unit pixels; and (f) analyzing a presence and/or a concentration of the biomolecule based on the voltage signal; wherein, a fluorescent marker or a chemiluminescent marker is added on the biomolecule before or after (b), and the incident light comprises a light emitted by the fluorescent marker or the chemiluminescent marker (see claims 1, 5, and 13 of ‘919).
Claims 6-7, 9, and 13-14 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of copending Application No. 17731919, in view of Yang et al., “Micro-optics for microfluidic analytical applications.” Chemical Society reviews vol. 47,4 (2018): 1391-1458. doi:10.1039/c5cs00649j.
Regarding instant claim 9, ‘919 teaches a biomolecular image sensor, comprising: an image sensing element, containing a plurality of unit pixels disposed in an array on a substrate, wherein each of the plurality of unit pixels contains at least one photoelectric conversion element, the photoelectric conversion element receives an incident light to generate electrons, and a surface of the image sensing element receiving the incident light is defined as a light receiving surface; a microstructure layer, disposed on the light receiving surface of the image sensing element and each of the plurality of microstructures corresponds to at least one unit pixel (see claim 1 of ‘919).
‘919 is silent towards an array formed by a plurality of microlenses, wherein a plurality of microstructures are formed between the plurality of microlenses.
Yang teaches an array being formed by a plurality of microlenses (see page 1404 “Another type of solid lens has an optical axis parallel to the chip plane, introducing light from the side wall of the chip,163,164 and can be directly fabricated on-chip. These microlenses are robust, vibration resistant, and simple to arrange in an array of solid microlenses of specific focal lengths.”), wherein a plurality of microstructures are formed between the plurality of microlenses (see figure 8).
It would have been prima facia obvious, at the time of the instant application, to use the array that was formed by microlenses and microstructures being formed between the plurality of microlenses as taught by Yang with the biomolecular image sensor taught by ‘919. Yang teaches that these claimed limitations are beneficial because Yang teaches that microlenses are an important and key optical component for focusing and collimating light in a microfluidic optical detection system (see page 1404). Yang further provides motivation by teaching that microlenses improve detection by focusing the light in the channel to increase the excitation power for optical measurements (see page 1404).
Regarding instant claims 6-7 and 13-14, Yang teaches using a microparticle as a carrier for the biomolecule (see table 1 under target sample).
Yang teaches the carrier is accommodated in the microstructure (see figure 7, see page 1411 “(a) (i) Optical image of the top view of an oxynitride photonic waveguide layer. (ii and iii) Schematic cross-sections of the waveguide structure situated before (ii) and at the bioreactor well (iii). The whole system was coated with a thin SiNx film (50 nm thickness) intended to accommodate the surface for the immobilization of biomolecules containing amino groups.”).
It would have been prima facia obvious, at the time of the instant application, a carrier such as a microparticle as taught by Yang with the biomolecular image sensor taught by ‘919. Yang teaches that these claimed limitations are beneficial because Yang teaches that microparticles are commonly used in the art of microfluidic devices (see table 1, see table 4).
This is a provisional nonstatutory double patenting rejection.
Claim 2 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of copending Application No. 17731919 in view of Niu et al., “Micro-Nano Processing of Active Layers in Flexible Tactile Sensors via Template Methods: A Review.” Small (Weinheim an der Bergstrasse, Germany) vol. 17,41 (2021): e2100804. doi:10.1002/smll.202100804.
Regarding instant claim 2, ‘919 teaches the biomolecular sensor of claim 1.
Niu teaches wherein the microstructure layer is an array formed by a plurality of inverted pyramidal or honeycomb microstructures (see page 22 “Chen et al. [201] sequentially coated Ag NWs solution and PDMS on the lithographic Si template with an inverted pyramid structure array, and placed the peeled Ag NWs/PDMS film face to face with the ITO/PET electrode to form a resistive pressure sensor”, see page 9 “Under certain electrolyte conditions, a cylindrical nanopore structure array with honeycomb-shaped structure is prepared by a simple, rapid, and economical oxidation process of aluminum electrode.”, see page 12).
It would have been prima facia obvious, at the time of the instant application, to use the microstructure array shapes taught by Niu with the biomolecular image sensor taught by ‘919. Niu teaches that these claimed limitations are beneficial because Niu teaches that pyramidal shapes can allow for higher sensitivity and a faster response time (see page 3 and table 1).
This is a provisional nonstatutory double patenting rejection.
Conclusion
No claim is allowed.
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/MCKENZIE A DUNN/Examiner, Art Unit 1678
/Ann Montgomery/Primary Examiner, Art Unit 1678