DETAILED ACTION
This action is in response to the amendment filed 2025 Mar 19. Claims 1-4, 6-13, 15-25 and new claim 26 are pending. Claims 5 and 14 are canceled. Claims 1-4, 6-13, and 15-26 are currently examined.
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 has canceled claim 14 which was previously rejected under 35 U.S.C. 112(a) as failing to comply with the written description requirement.
Applicant has integrated canceled claim 5 into claim 1, and adjusted claim 6 to depend on claim 1.
Applicant has added claim 26 similar to claim 6.
Applicant has amended claims 2, 10 and 23 to resolve all previous objections.
Applicant has amended claims 2, 18, 19, 21, and 25 to resolve their previous rejections under 35 U.S.C. 112(b).
Response to Arguments
Applicant argues in p.7 of remarks regarding claim 1 that “nowhere in Rothberg are the dimensions of the structures disclosed so no disclosure of a nanostructure is provided in Rothberg.” Applicant argues in p.10 that Rothberg fails to disclose or suggest a metallic nanostructure disposed on each receptor site of the two dimensional array of receptor sites on the surface. MPEP 2111 states that claims must be given their broadest reasonable interpretation in light of the specification. Examiner asserts that since 0317 discloses that the structures 5-711 “may comprise surface plasmon or nano-antenna structures”, and 0038 discloses “nano-scale” may be used in the present disclosure to refer to a structure having at least one dimension or minimum feature size on the order of 150 nanometers (nm) or less, that what Rothberg discloses is within the broadest reasonable interpretation of nanostructure.
Applicant argues on p.7 that the structures disclosed by Rothberg in Figs. 5-7C, 5-711 are not disposed on receptor sites; and argues on p.8-10 that the additional references cited do not disclose this limitation either.
Applicant’s arguments 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.
Applicant argues in p.10 that regarding claim 26 and previous claim 6, no metal structures are disclosed in paragraph 0557 of Rothberg and “This paragraph discloses only bottom surfaces of sample wells which do not consist of a metal nanostructure.”
Applicant’s arguments with respect to claim(s) 6 have been considered but are moot because the new ground of rejection does not rely on any citation applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 6 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
It is unclear how claim 6 can depend on claim 5 which has been canceled. For purposes of examination, this claim will be interpreted to depend upon claim 1.
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.
Claims 1-2, 6, 9-13, 16, 18-21, and 25-26 are rejected under 35 U.S.C. 103 as being unpatentable over Rothberg [Rothberg et al, US 20160370291 A1] in view of Bowen [Bowen et al, US 20180073065 A1].
Regarding claim 1, Rothberg discloses an apparatus [Fig. 2-1B, Fig. 3-2] for determining the presence or concentration of target molecules [0498 a single molecule can be identified, Title: detecting molecules, 0013 integrated device may be used to detect the presence of particular analytes], the apparatus comprising:
a surface [3-201] defining a two dimensional array of receptor sites [sample wells 3-203; para 0260 array of sample wells];
a waveguide [3-220, para 0256; in combination with 3-210] arranged to receive at least a portion of incident electromagnetic radiation [from excitation source 3-230], divide the electromagnetic radiation [0288 splitting waveguides from a single waveguide to multiple waveguides] and direct a portion of the electromagnetic radiation to each one of the receptor sites [0288 allows for excitation energy to reach multiple rows or columns of sample wells];
a detector comprising a two dimensional array of sensing elements [0260 array of sensors], each sensing element arranged to receive electromagnetic radiation from a different receptor site of the two dimensional array of receptor sites [0260 each sample well has a corresponding sensor]; and
a spectral filter provided between the surface and the detector [0260 3-260 may include a filter that selectively transmits emission energy of one or more markers used to label a sample].
Rothberg does not disclose a metallic nanostructure disposed on each receptor site of the two dimensional array of receptor sites on the surface.
Rothberg does disclose metallic nanostructures disposed on a surface [Fig. 5-7C, 5-711; para 0317 “The energy-enhancing structures 5-711 may comprise surface plasmon or nano-antenna structures formed in conductive materials on an optically transparent layer 5-235, according to some embodiments.”; 0038 The term “nano-scale” may be used in the present disclosure to refer to a structure having at least one dimension or minimum feature size on the order of 150 nanometers (nm) or less, but not greater than approximately 500 nm.].
Bowen teaches a metallic nanostructure disposed on each receptor site of the two dimensional array of receptor sites on the surface [Fig. 2, 0023; 0057 metal nanogratings on which nanowells could be formed, metal nanoplug in a nanowell].
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have a metallic nanostructure disposed on each receptor site of the two dimensional array of receptor sites on the surface in order to allow for precise subnanometer control over nanoparticle spacings [Bowen 0057].
Regarding claim 2, Rothberg in view of Bowen [citations to Rothberg] discloses the apparatus of claim 1 further comprising a radiation source operable to produce electromagnetic radiation [3-230 Excitation Source] and wherein the waveguide is arranged to receive at least a portion of the electromagnetic radiation produced by the radiation source [Fig. 2 3-220 arranged to receive light from 3-230 as dashed line], divide the electromagnetic radiation [0288 splitting waveguides from a single waveguide to multiple waveguides] and direct a portion of the electromagnetic radiation to each receptor site of the two dimensional array of receptor sites [0288 allows for excitation energy to reach multiple rows or columns of sample wells].
Regarding claim 6, Rothberg in view of Bowen [citations to Rothberg] discloses the apparatus of claim 1 further comprising a receptor provided on each metallic nanostructure [adherent 5-211; 0317: “an adherent 5-211 formed adjacent the excitation-energy-enhancing structures… Samples 5-101 diffusing into the region may be retained, temporarily or permanently, by the adherent 5-211”].
Regarding claim 9, Rothberg in view of Bowen [citations to Rothberg] discloses the apparatus of claim 1 wherein the waveguide [3-220] is disposed between the detector [3-275] and the surface defining the two dimensional array of receptor sites [3-203].
Regarding claim 10, Rothberg in view of Bowen [citations to Rothberg] discloses the apparatus of claim 1 wherein the waveguide comprises a generally planar body [Fig. 3-2, 3-220; para 0256 waveguide 3-220 may be formed in a layer] and wherein the surface defining the two dimensional array of receptor sites is a surface of said body [bottom surface of 3-203 is top surface of 3-210].
Regarding claim 11, Rothberg in view of Bowen [citations to Rothberg] discloses the apparatus of claim 1 wherein the waveguide comprises an integrated optics plate [0288 splitting waveguides from a single waveguide] arranged to receive the electromagnetic radiation output by a radiation source at an input and to spread out the electromagnetic radiation over the surface defining the two dimensional array of receptor sites [0288 splitting waveguides from a single waveguide to multiple waveguides allows for excitation energy to reach multiple rows or columns of sample wells].
Regarding claim 12, Rothberg in view of Bowen [citations to Rothberg] discloses the apparatus of claim 1 wherein the waveguide comprises a plurality of beam splitters or optical waveguide splitters arranged to spread the incident radiation over the surface defining the two dimensional array of receptor sites [0288 splitting waveguides from a single waveguide to multiple waveguides allows for excitation energy to reach multiple rows or columns of sample wells].
Regarding claim 13, Rothberg in view of Bowen [citations to Rothberg] discloses the apparatus of claim 1 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 [0570 grating used to couple waveguide to sample well for each pixel].
Regarding claim 16, Rothberg in view of Bowen [citations to Rothberg] discloses the apparatus of claim 1 further comprising a user interface for receiving signals from the detector [Fig. 2-1B, User Interface 2-116, 0242 Additionally, the 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 on the integrated device].
Regarding claim 18, Rothberg in view of Bowen [citations to Rothberg] discloses the apparatus of claim 1 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 [0260 filter that selectively transmits emission energy of one or more markers used to label a sample; 0407 wavelength filter, regions 7-708 and 7-709 of multiwavelength filter 7-700 are disposed adjacent to difference sensing elements 7-710 and 7-711].
Regarding claim 19, Rothberg in view of Bowen [citations to Rothberg] discloses the apparatus of claim 1 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 [Fig. 4-5, 0288 splitting waveguides from a single waveguide to multiple waveguides allows for excitation energy to reach multiple rows or columns of sample wells].
Regarding claim 20, Rothberg in view of Bowen [citations to Rothberg] discloses the apparatus of claim 1 wherein the waveguide comprises a plurality of waveguide channels and waveguide splitters [Fig. 4-5, 0288 splitting waveguides from a single waveguide to multiple waveguides allows for excitation energy to reach multiple rows or columns of sample wells].
Regarding claim 21, Rothberg in view of Bowen [citations to Rothberg] discloses the apparatus of claim 1 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 [0288 splitting waveguides from a single waveguide to multiple waveguides allows for excitation energy to reach multiple rows or columns of sample wells].
Regarding claim 25, Rothberg in view of Bowen [citations to Rothberg] discloses the apparatus of claim 21 wherein each coupling optic comprises a microlens array 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 dimensional array of receptor sites [0602 A refractive lens array may be created in any suitable way to improve efficiency of focusing of excitation into and collection of emission light from the sample well. In some embodiments, a refractive lens array may be a “gapless” array to minimize “dead zones” on the lens array. In the embodiment illustrated in FIG. 11-11, a refractive microlens array is shown with no gaps between individual lenses].
Regarding claim 26, Rothberg discloses an apparatus [Fig. 2-1B, Fig. 3-2] for determining the presence or concentration of target molecules [0498 a single molecule can be identified, Title: detecting molecules, 0013 integrated device may be used to detect the presence of particular analytes], the apparatus comprising:
a surface [3-201] defining a two dimensional array of receptor sites [sample wells 3-203; para 0260 array of sample wells];
a waveguide [3-220, para 0256; in combination with 3-210] arranged to receive at least a portion of incident electromagnetic radiation [from excitation source 3-230], divide the electromagnetic radiation [0288 splitting waveguides from a single waveguide to multiple waveguides] and direct a portion of the electromagnetic radiation to each one of the receptor sites [0288 allows for excitation energy to reach multiple rows or columns of sample wells];
a detector comprising a two dimensional array of sensing elements [0260 array of sensors], each sensing element arranged to receive electromagnetic radiation from a different receptor of the two dimensional array of receptor sites [0260 each sample well has a corresponding sensor]; and
a spectral filter provided between the surface and the detector [0260 3-260 may include a filter that selectively transmits emission energy of one or more markers used to label a sample].
Rothberg does not disclose 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.
Bowen teaches a metallic nanostructure disposed on each receptor site of the two dimensional array of receptor sites on the surface [Fig. 2, 0023; 0057 metal nanogratings on which nanowells could be formed, metal nanoplug in a nanowell]; and
a receptor provided on each metallic nanostructure [0057 Nanoparticle constructs (dimers, n-mers) formed using DNA origamis or linker molecules such as cucurbit[n]urils are also attractive for loading into wells.]
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have 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 in order to allow for precise subnanometer control over nanoparticle spacings [Bowen 0057].
Claims 3-4 are rejected under 35 U.S.C. 103 as being unpatentable over Rothberg in view of Bowen in view of Durrer [Durrer et al, US 20140093948 A1].
Regarding claim 3, Rothberg in view of Bowen discloses the apparatus of claim 2, but not explicitly wherein the radiation source is a broadband radiation source.
Rothberg does disclose wherein the radiation source comprises a light emitting diode [0429 LEDs may be used as excitation source].
Durrer teaches illuminating sample wells [Fig. 2, 0143] with light from a white LED [0122, 0126].
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have used a broadband radiation source in order to have flexible choice of excitation wavelength and 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 0122].
Regarding claim 4, Rothberg in view of Bowen discloses the apparatus of claim 2, wherein the radiation source comprises a light emitting diode [0429 LEDs may be used as excitation source].
Rothberg does not disclose wherein the radiation source comprises a white light emitting diode.
Durrer teaches illuminating sample wells [Fig. 2, 0143] with light from a white LED [0122, 0126].
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have used a white LED in order to have flexible choice of excitation wavelength and 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 0122].
Claims 7-8 are rejected under 35 U.S.C. 103 as being unpatentable over Rothberg in view of Bowen in view of Kanukurthy [Kanukurthy et al, US 20130169967 A1].
Regarding claim 7, Rothberg in view of Bowen [citations to Rothberg] discloses the apparatus of claim 1 comprising a printed circuit board [0460 printed circuit board 9-506 with excitation source].
Rothberg in view of Bowen does not disclose wherein the detector is mounted on the printed circuit board.
Kanukurthy discloses wherein a detector is mounted on a printed circuit board [0079].
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have in Rothberg in view of Bowen wherein the detector is mounted on the printed circuit board in order to establish a desired angle between light source and detector [Kanukurthy 0081].
Regarding claim 8, Rothberg in view of Bowen [citations to Rothberg] discloses the apparatus of claim 2 further comprising a printed circuit board and wherein the radiation source is mounted on the printed circuit board [0460 printed circuit board 9-506 with excitation source].
Rothberg in view of Bowen does not disclose wherein the radiation source and the detector are both mounted on the printed circuit board.
Kanukurthy discloses wherein disclose wherein the radiation source and the detector are both mounted on the printed circuit board [0079 first and second light sources 512 and 514 and a detector 520 can be mounted on the same support 550, such as a printed circuit board].
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have in Rothberg in view of Bowen wherein the radiation source and the detector are both mounted on the printed circuit board in order to establish a desired angle between light source and detector [Kanukurthy 0081].
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Rothberg in view of Bowen in view of Lee [KR 20150065065 A].
Regarding claim 15, Rothberg in view of Bowen discloses the apparatus of claim 1, but not further comprising one or more sensors operable to determine one or more ambient conditions.
Lee teaches one or more sensors operable to determine one or more ambient conditions [a temperature sensor 150 for checking the internal temperature of the housing 101].
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have one or more sensors operable to determine one or more ambient conditions in order to confirm that the environment is suitable to conducting inspection [Lee By displaying the progress of the biomolecule inspection through the display 103 according to the ambient temperature around the platform accommodating chamber 160 sensed by the temperature sensor 150, It is possible to confirm that the environment is suitable for conducting the biomolecule inspection and accordingly, appropriate measures can be taken].
Claim 17 is rejected under 35 U.S.C. 103 as being unpatentable over Rothberg in view of Bowen in view of Song [Joon Myong Song, Guy D. Griffin, Tuan Vo-Dinh, Application of an integrated microchip system with capillary array electrophoresis to optimization of enzymatic reactions, Analytica Chimica Acta, Volume 487, Issue 1, 2003, Pages 75-82, ISSN 0003-2670, https://doi.org/10.1016/S0003-2670(03)00515-4].
Regarding claim 17, Rothberg in view of Bowen discloses the apparatus of claim 1 but not wherein the spectral filter has a full width at half maximum bandwidth of 10 nm or less.
Song teaches measuring concentration [Abstract] using a spectral filter [Fig. 1 interference band pass filter] wherein the spectral filter has a full width at half maximum bandwidth of 10 nm or less [2.3. Fluorescence detection and capillary array electrophoresis: “central wavelength: 656 nm, FWHM: 10 nm, Edmund Industrial Optics”].
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have wherein the spectral filter has a full width at half maximum bandwidth of 10 nm or less in order to remove laser scattering [Song 2.3. Fluorescence detection and capillary array electrophoresis].
Claims 22-23 are rejected under 35 U.S.C. 103 as being unpatentable over Rothberg in view of Bowen in view of Jain [Jain et al, US 6510276 B1, pub 2003].
Regarding claim 22, Rothberg in view of Bowen discloses the apparatus of claim 21 but not wherein each coupling optic comprises a patterned portion at an end of a waveguide channel within a body of the waveguide.
Rothberg does disclose optical coupling elements to couple energy from the well towards the sensor [0238], and wherein each coupling optic comprises a coupler [0288 star splitter or coupler, a Y splitter, and/or an evanescent coupler, or a multi-mode interference splitter (MMI)].
Jain teaches the equivalence of other coupling means known in the waveguide art with a patterned portion at an end of a waveguide channel within a body of the waveguide [col 10 L58-61 “Waveguide 810 is preferably coupled to source 810 via a mechanical splice 820 or fiber side-coupling through v-grooves etched in the outer cladding or any other coupling means known in the waveguide art.”].
In view of this it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have wherein each coupling optic comprises a patterned portion at an end of a waveguide channel within a body of the waveguide.
Regarding claim 23, Rothberg in view of Bowen discloses the apparatus of claim 22 but not 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.
Rothberg does disclose optical coupling elements to couple energy from the well towards the sensor [0238], and wherein each coupling optic comprises a coupler [0288 star splitter or coupler, a Y splitter, and/or an evanescent coupler, or a multi-mode interference splitter (MMI)].
Jain teaches the equivalence of other coupling means known in the waveguide art with a patterned portion at an end of a waveguide channel within a body of the waveguide [col 10 L58-61 “Waveguide 810 is preferably coupled to source 810 via a mechanical splice 820 or fiber side-coupling through v-grooves etched in the outer cladding or any other coupling means known in the waveguide art.”].
In view of this it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have 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.
Claim 24 is rejected under 35 U.S.C. 103 as being unpatentable over Rothberg in view of Bowen in view of Ward [US 4653844 A, pub 1987].
Regarding claim 24, Rothberg in view of Bowen discloses the apparatus of claim 21, but not explicitly wherein each coupling optic comprises a mirror or a prism.
Rothberg does disclose wherein each coupling optic comprises a coupler [0288 star splitter or coupler, a Y splitter, and/or an evanescent coupler, or a multi-mode interference splitter (MMI)].
Ward teaches that prism couplers need only a small force to hold prism and waveguide together, provide simple coupler structure, are low cost, and have manufacture suitable for automation [col. 4 L15-21].
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have in Rothberg wherein each coupling optic comprises a prism.
Conclusion
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/ADRIAN IGNACIO SILVA/Examiner, Art Unit 2877
/UZMA ALAM/Supervisory Patent Examiner, Art Unit 2877
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