Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Status of the Application
Claims 1-9, 11-13 and 16-19 are pending and under examination.
Claim Objections
The numbering of claims is not in accordance with 37 CFR 1.126 which requires the original numbering of the claims to be preserved throughout the prosecution. When claims are canceled, the remaining claims must not be renumbered. When new claims are presented, they must be numbered consecutively beginning with the number next following the highest numbered claims previously presented (whether entered or not).
In the instant case, the last two claims of the most recent claim set are both enumerated as “18”.
The second of these two, misnumbered claim 18 been renumbered claim 19.
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.
Yun et al.
Claim(s)1, 2, 4-9 and 11-13 are rejected under 35 U.S.C. 102(a) (1) and (a) (2) as being anticipated by Yun et al.(WO2020086510; cited in the IDS filed 18 January 2023).
Prior to the effective filing date of the claimed invention, Yun et al. teach systems comprising optical readable capture particles, i.e. ORCP, that comprise resonator particles coated with fluorescent emitters, i.e. optical barcode, and with nucleic acid strands comprising oligonucleotide- based cellular barcodes. Furthermore, Yun et al. teach the nucleic acid strand also comprises a cleavable region, a primer region, a UMI and a capture region, such as Poly-dT (e.g. Entire Yun reference and especially para 0045,pg. 6; para 0077, pg. 11-12, Fig. 1).
Furthermore, Yun et al. teach ORCP embodiments wherein the resonator is a laser particle coated with nucleic acid strands. Furthermore, Yun et al. teach the particle is coated in a transparent coating such as a SiO2 or Si3N4 coating prior to the attachment of nucleic acids. Furthermore, Yun et al. teach the unique optical barcode facilitates a spectral readout (e.g. Entire Yun reference and especially transparent coating and nucleic acid coating as in para 0084-0086, pg. 14-16; readout as in para 0087-0091, pg. 16-18; Fig. 3A; Fig. 5A and 5B; Fig. 7).
Furthermore, Yun et al. teach embodiments of analysis wherein an ORCP, i.e. laser particle comprising nucleic acid capture strands, is combined with a single cell in a compartment. The optical barcode component of the ORCP system is read to gauge fluorescent intensity of the associated reporter. Subsequently, the cells are lysed and the cellular content is captured by nucleic acid capture strands on the laser particle ( e.g. Entire Yun reference and especially para 0095-0097, pg. 18-20; Fig. 6 and 7).
Furthermore, Yun et al. teach embodiments of computing systems that are used for data collection, analysis and storage, wherein these systems comprise non-volatile memory and storage ( e.g. Entire Yun reference and especially para 0108-0112, pg. 24; non-volatile memory and storage as in para 0113-0116,pg. 24-25; Fig. 9-10).
Furthermore, Yun et al. teach embodiments comprising chromatin analysis wherein cellular DNA content is fragmented and ligated with adapters through transposition with Tn5 transposase and the resultant DNA fragments are captured by nucleic acid strands on an ORCP and subjected to sequencing. The results are generated by readout of the optical and cellular barcodes (e.g. Entire Yun reference and especially…'accessible chromatin in single cells using sequencing' (scATAC-seq) (Sapathy et al. Nature Biotechnology 37, 925-936 (2019)) is used with ORCPs to measure chromatin expression and associate that with some cellular/nuclear phenotypic property. chromatin is instead captured by the capture sites of the ORCP. This can be accomplished by isolating cells or cell nuclei from a cell suspension and performing a bulk transposition with transposase Tn5. This enzyme cuts and ligates adapter sequences to the nuclear chromatin, in open, accessible regions of DNA The single cells/nuclei are then isolated with ORCPs, for example, in a water-in-oil droplets (FIG. 7) or in microwells (FIG. 6). The DNA fragments generated by transposition are then integrated into the DNA barcodes on the ORCP, thus preparing a library ready for sequencing. Phenotypic properties of the cell/nuclei can be read following their isolation with a particular ORCP as well as the ORCP' s optical barcode. The generation of chromatin sequencing data can then be mapped to any phenotypic measurement through the known association of the ORCP' s cellular barcode with its optical barcode… as in para 0118,pg. 26).
Regarding the limitations recited in claim 1:
the laser particle comprising:
(i) a coating configured to physically associate the cellular coding construct with the cellular entity; ... wherein (a) the structurally coded oligonucleotide and the laser particle identify the cellular entity and
(b) the coating is distinct from the structurally coded oligonucleotide.
The limitation “the structurally coded oligonucleotide and the laser particle identify the cellular entity” is considered an intended use.
See MPEP 2114.II: MANNER OF OPERATING THE DEVICE DOES NOT DIFFERENTIATE APPARATUS CLAIM FROM THE PRIOR ART
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"[A]pparatus claims cover what a device is, not what a device does." Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990) (emphasis in original). A claim containing a "recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus" if the prior art apparatus teaches all the structural limitations of the claim. Ex parte Masham, 2 USPQ2d 1647 (Bd. Pat. App. & Inter. 1987) (The preamble of claim 1 recited that the apparatus was "for mixing flowing developer material" and the body of the claim recited "means for mixing ..., said mixing means being stationary and completely submerged in the developer material." The claim was rejected over a reference which taught all the structural limitations of the claim for the intended use of mixing flowing developer. However, the mixer was only partially submerged in the developer material. The Board held that the amount of submersion is immaterial to the structure of the mixer and thus the claim was properly rejected.).
Therefore, a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim.
In the instant case, Yun et al. teach the particle is coated in a transparent coating such as a SiO2 or Si3N4 coating prior to the attachment of nucleic acids (e.g. Entire Yun reference and especially transparent coating and nucleic acid coating as in para 0084-0086, pg. 14-16; readout as in para 0087-0091, pg. 16-18; Fig. 3A; Fig. 5A and 5B; Fig. 7).
Furthermore, Yun et al. teach embodiments of analysis wherein an ORCP, i.e. laser particle comprising nucleic acid capture strands, is combined with a single cell in a compartment. The optical barcode component of the ORCP system is read to gauge fluorescent intensity of the associated reporter. Subsequently, the cells are lysed and the cellular content is captured by nucleic acid capture strands on the laser particle ( e.g. Entire Yun reference and especially para 0095-0097, pg. 18-20; Fig. 6 and 7).
Therefore, as Yun et al. teach a particle comprising a transparent coating that is distinct from an associated coating of nucleic acid capture strands that are physically associated with the content of a cell, the teaching of Yun meets the requirements of these limitations.
Therefore, Yun et al. teach systems for analysis comprising a laser particle comprising a transparent coating and then coated with barcoded nucleic acid strands and a single cell, wherein the chromatin of the cell, i.e. specified cellular entity, is analyzed by association with the laser particle and with the barcoded nucleic acid strands through capture and subsequent sequencing to generate genetic sequence data, DNA data and identification data, i.e. identify the cellular entity. Furthermore, the resulting data is read out by computing systems comprising non-volatile memory and storage.
Therefore, Yun et al. teach claims 1,2 and 4-8.
Furthermore, as Yun et al. teach the associated nucleic acid strands comprising multiple regions, including a cleavable region, a primer region, a UMI and a capture region, Yun et al. teach claims 9, 12 and 13.
Furthermore, as Yun et al. teach multiple embodiments of arrays of compartments each comprising a single cell and a barcoded laser particle, Yun et al. teach claim 11.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Yun et al.
Claim(s) 1, 2, 4-9 and 11-13 are rejected under 35 U.S.C. 103 as being unpatentable over Yun et al.(WO2020086510; cited in the IDS filed 18 January 2023).
In the embodiment wherein the optical readable capture particles of Yun may comprise optional features, the teaching of Yun is applied to render claims 1, 2, 4-9 and 11-13 obvious.
Prior to the effective filing date of the claimed invention, Yun et al. teach systems comprising optical readable capture particles, i.e. ORCP, that comprise resonator particles coated with fluorescent emitters, i.e. optical barcode, and with nucleic acid strands comprising oligonucleotide- based cellular barcodes. Furthermore, Yun et al. teach the nucleic acid strand also comprises a cleavable region, a primer region, a UMI and a capture region, such as Poly-dT (e.g. Entire Yun reference and especially para 0045,pg. 6; para 0077, pg. 11-12, Fig. 1).
Furthermore, Yun et al. teach ORCP embodiments wherein the resonator is a laser particle coated with nucleic acid strands. Furthermore, Yun et al. teach the particle may be coated in a transparent coating such as a SiO2 or Si3N4 coating prior to the attachment of nucleic acids. Furthermore, Yun et al. teach the unique optical barcode facilitates a spectral readout (e.g. Entire Yun reference and especially transparent coating and nucleic acid coating as in para 0084-0086, pg. 14-16; readout as in para 0087-0091, pg. 16-18; Fig. 3A; Fig. 5A and 5B; Fig. 7).
Furthermore, Yun et al. teach embodiments of analysis wherein an ORCP, i.e. laser particle comprising nucleic acid capture strands, is combined with a single cell in a compartment. The optical barcode component of the ORCP system is read to gauge fluorescent intensity of the associated reporter. Subsequently, the cells are lysed and the cellular content is captured by nucleic acid capture strands on the laser particle ( e.g. Entire Yun reference and especially para 0095-0097, pg. 18-20; Fig. 6 and 7).
Furthermore, Yun et al. teach embodiments of computing systems that are used for data collection, analysis and storage, wherein these systems comprise non-volatile memory and storage ( e.g. Entire Yun reference and especially para 0108-0112, pg. 24; non-volatile memory and storage as in para 0113-0116,pg. 24-25; Fig. 9-10).
Furthermore, Yun et al. teach embodiments comprising chromatin analysis wherein cellular DNA content is fragmented and ligated with adapters through transposition with Tn5 transposase and the resultant DNA fragments are captured by nucleic acid strands on an ORCP and subjected to sequencing. The results are generated by readout of the optical and cellular barcodes (e.g. Entire Yun reference and especially…'accessible chromatin in single cells using sequencing' (scATAC-seq) (Sapathy et al. Nature Biotechnology 37, 925-936 (2019)) is used with ORCPs to measure chromatin expression and associate that with some cellular/nuclear phenotypic property. chromatin is instead captured by the capture sites of the ORCP. This can be accomplished by isolating cells or cell nuclei from a cell suspension and performing a bulk transposition with transposase Tn5. This enzyme cuts and ligates adapter sequences to the nuclear chromatin, in open, accessible regions of DNA The single cells/nuclei are then isolated with ORCPs, for example, in a water-in-oil droplets (FIG. 7) or in microwells (FIG. 6). The DNA fragments generated by transposition are then integrated into the DNA barcodes on the ORCP, thus preparing a library ready for sequencing. Phenotypic properties of the cell/nuclei can be read following their isolation with a particular ORCP as well as the ORCP' s optical barcode. The generation of chromatin sequencing data can then be mapped to any phenotypic measurement through the known association of the ORCP' s cellular barcode with its optical barcode… as in para 0118,pg. 26).
Regarding the limitations recited in claim 1:
the laser particle comprising:
(i) a coating configured to physically associate the cellular coding construct with the cellular entity; ... wherein (a) the structurally coded oligonucleotide and the laser particle identify the cellular entity and
(b) the coating is distinct from the structurally coded oligonucleotide.
The limitation “the structurally coded oligonucleotide and the laser particle identify the cellular entity” is considered an intended use.
See MPEP 2114.II: MANNER OF OPERATING THE DEVICE DOES NOT DIFFERENTIATE APPARATUS CLAIM FROM THE PRIOR ART
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"[A]pparatus claims cover what a device is, not what a device does." Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990) (emphasis in original). A claim containing a "recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus" if the prior art apparatus teaches all the structural limitations of the claim. Ex parte Masham, 2 USPQ2d 1647 (Bd. Pat. App. & Inter. 1987) (The preamble of claim 1 recited that the apparatus was "for mixing flowing developer material" and the body of the claim recited "means for mixing ..., said mixing means being stationary and completely submerged in the developer material." The claim was rejected over a reference which taught all the structural limitations of the claim for the intended use of mixing flowing developer. However, the mixer was only partially submerged in the developer material. The Board held that the amount of submersion is immaterial to the structure of the mixer and thus the claim was properly rejected.).
Therefore, a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim.
In the instant case, Yun et al. teach the particle may be coated in a transparent coating such as a SiO2 or Si3N4 coating prior to the attachment of nucleic acids (e.g. Entire Yun reference and especially transparent coating and nucleic acid coating as in para 0084-0086, pg. 14-16; readout as in para 0087-0091, pg. 16-18; Fig. 3A; Fig. 5A and 5B; Fig. 7).
Furthermore, Yun et al. teach embodiments of analysis wherein an ORCP, i.e. laser particle comprising nucleic acid capture strands, is combined with a single cell in a compartment. The optical barcode component of the ORCP system is read to gauge fluorescent intensity of the associated reporter. Subsequently, the cells are lysed and the cellular content is captured by nucleic acid capture strands on the laser particle ( e.g. Entire Yun reference and especially para 0095-0097, pg. 18-20; Fig. 6 and 7).
Therefore, as Yun teach multiple embodiments comprising optional features such as a distinct transparent coating on the particles prior to attachment of capture oligonucleotides, it would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date to modify the particles of Yun et al. to include optional features such as a distinct transparent coating as taught in other embodiments of Yun as a skilled artisan would recognize that these claim elements were known in the art and one of skill in the art could have combined these elements by known methods with no change in their respective functions, and the combination would have yielded the predictable outcome of systems comprising laser particles for optical tagging of single cells.
Therefore, as Yun et al. teach a particle comprising a transparent coating that is distinct from an associated coating of nucleic acid capture strands that are physically associated with the content of a cell, the teaching of Yun meets the requirements of these limitations.
Therefore, Yun et al. teach systems for analysis comprising a laser particle comprising a transparent coating and then coated with barcoded nucleic acid strands and a single cell, wherein the chromatin of the cell, i.e. specified cellular entity, is analyzed by association with the laser particle and with the barcoded nucleic acid strands through capture and subsequent sequencing to generate genetic sequence data, DNA data and identification data, i.e. identify the cellular entity. Furthermore, the resulting data is read out by computing systems comprising non-volatile memory and storage.
Therefore, Yun et al. render obvious claims 1,2 and 4-8.
Furthermore, as Yun et al. teach the associated nucleic acid strands comprising multiple regions, including a cleavable region, a primer region, a UMI and a capture region, Yun et al. render obvious claims 9, 12 and 13.
Furthermore, as Yun et al. teach multiple embodiments of arrays of compartments each comprising a single cell and a barcoded laser particle, Yun et al. render obvious claim 11.
Yun et al. and Kwok et al.
Claim(s) 3 is rejected under 35 U.S.C. 103 as being unpatentable over Yun as applied to claims 1, 2, 4-9 and 11-13 above, and further in view of Kwok et al. ("Multiplexed laser particles for spatially resolved single-cell analysis." Light: Science & Applications 8.1 (2019): 74; 5 pages; published online 21 August 2019; cited in the IDS filed 18 January 2023).
The teachings of Yun et al. as applied in the rejections above are incorporated in this rejection.
As discussed above, Yun et al. teach systems for analysis comprising a laser particle and barcoded nucleic acid strands and a single cell, wherein the chromatin of the cell, i.e. specified cellular entity, is analyzed by association with the laser particle and with the barcoded nucleic acid strands, i.e. genetic sequence data, DNA data and identification data, and resulting data is analyzed by computing systems comprising non-volatile memory and storage.
However, Yun et al. do not expressly teach claim 3.
Prior to the effective filing date of the claimed invention, like Yun et al., Kwok et al. teach systems comprising laser particles for optical tagging of single cells. Furthermore, Kwok et al. teach particles that are less than 3mm have several advantages for cellular barcoding . Furthermore, Kwok et al. teach such particles can also comprise DNA barcodes to facilitate cell analysis (e.g. Entire Kwok reference and especially… Our recent study employed silica coated
III–V semiconductor microdisk LPs with diameters of ~2 μm and total thicknesses of ~400 nm25. Our microdisk LPs have several key properties that make them more suitable for cellular barcoding than the previous designs, including relatively small sizes (~0.1% of the cell
volume), stability in aqueous environments, biocompatibility, and tunable wavelengths over a wide range… as in 2nd para, Laser particles for single-cell analysis section, pg. 3 of 5; …LP cell tagging is also compatible with high-throughput methods, including microdroplet-based26 and split-pool barcoding27, which introduce cell-specific DNA barcodes for highly parallel analysis as long as an association between the optical LP barcode and the DNA barcode is made… as in 3rd para, Laser particles for single-cell analysis section, pg. 3-4 of 5; Fig 2, pg. 4 of 5).
Therefore, as both Yun et al. and Kwok et al. teach systems comprising laser particles for optical tagging of single cells, it would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date to modify the teachings of Yun et al. to include laser particles that have a diameter around 2mm, wherein the particles also comprise DNA barcodes as taught by Kwok et al. as a person of ordinary skill in the art would recognize that Kwok et al. teach the merits of laser particles with small diameters ( e.g. including relatively small sizes (~0.1% of the cell volume), stability in aqueous environments, biocompatibility, and tunable wavelengths over a wide range). Furthermore, a skilled artisan would recognize that these claim elements were known in the art and one of skill in the art could have combined these elements by known methods with no change in their respective functions, and the combination would have yielded the predictable outcome of systems comprising laser particles for optical tagging of single cells.
Therefore, the combined teachings of Yun et al. and Kwok et al. render obvious claim 3.
Yun et al. and Zhu et al.
Claim(s) 16 and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Yun as applied to claims 1, 2, 4-9 and 11-13 above, and further in view of Zhu et al.( "Poly (l‐lysine)‐modified silica nanoparticles for the delivery of antisense oligonucleotides." Biotechnology and applied biochemistry 39.2 (2004): 179-187).
.
The teachings of Yun et al. as applied in the rejections above are incorporated in this rejection.
As discussed above, Yun et al. teach systems for analysis comprising a laser particle and barcoded nucleic acid strands and a single cell, wherein the chromatin of the cell, i.e. specified cellular entity, is analyzed by association with the laser particle and with the barcoded nucleic acid strands, i.e. genetic sequence data, DNA data and identification data, and resulting data is analyzed by computing systems comprising non-volatile memory and storage.
However, Yun et al. do not expressly teach claims 16 and 17.
Prior to the effective filing date of the claimed invention, like Yun et al., Zhu et al. teach systems comprising coated particles. Furthermore, Zhu et al. teach silica particles are known in the art that are coated with polylysine prior to attachment of nucleic acid molecules ( e.g. Entire Zhu reference and especially PMS-NP as in Preparation and characterization of PMS-NP, Materials and Methods, pg. 180; Discussion section, pg. 186-187; Figure 8, pg. 186).
Therefore, it would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date to modify the teachings of Yun et al. to include the teaching of Zhu as a person of ordinary skill in the art would recognize that these claim elements were known in the art and one of skill in the art could have combined these elements by known methods with no change in their respective functions, and the combination would have yielded the predictable outcome of the claimed invention.
Therefore, the combined teachings of Yun and Zhu render obvious claims 16 and 17.
Yun et al. and Riggio et al.
Claim(s) 16, 17 and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Yun as applied to claims 1, 2, 4-9 and 11-13 above, and further in view of Riggio et al. (""Poly-l-lysine-coated magnetic nanoparticles as intracellular actuators for neural guidance." International journal of nanomedicine (2012): 3155-3166.).
The teachings of Yun et al. as applied in the rejections above are incorporated in this rejection.
As discussed above, Yun et al. teach systems for analysis comprising a laser particle and barcoded nucleic acid strands and a single cell, wherein the chromatin of the cell, i.e. specified cellular entity, is analyzed by association with the laser particle and with the barcoded nucleic acid strands, i.e. genetic sequence data, DNA data and identification data, and resulting data is analyzed by computing systems comprising non-volatile memory and storage.
However, Yun et al. do not expressly teach claims 16, 17 and 19.
Prior to the effective filing date of the claimed invention, like Yun et al., Riggio et al. teach systems comprising coated particles. Furthermore, Riggio et al. teach particles are known in the art that are coated with polylysine as well as N-hydroxysuccinimide ( e.g. Entire Riggio reference and especially ARA-MNPs as in Synthesis of PLL-Fe3O4 nanoparticles, Materials and Methods, pg. 3156-3157).
Therefore, it would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date to modify the teachings of Yun et al. to include the teaching of Riggio as a person of ordinary skill in the art would recognize that these claim elements were known in the art and one of skill in the art could have combined these elements by known methods with no change in their respective functions, and the combination would have yielded the predictable outcome of the claimed invention.
Therefore, the combined teachings of Yun and Riggio render obvious claims 16, 17 and 19.
Yun et al. and Yun II.
Claim(s) 18 is rejected under 35 U.S.C. 103 as being unpatentable over Yun as applied to claims 1, 2, 4-9 and 11-13 above, and further in view of Yun et al. (US20190296521), i.e. Yun II.
The teachings of Yun et al. as applied in the rejections above are incorporated in this rejection.
As discussed above, Yun et al. teach systems for analysis comprising a laser particle and barcoded nucleic acid strands and a single cell, wherein the chromatin of the cell, i.e. specified cellular entity, is analyzed by association with the laser particle and with the barcoded nucleic acid strands, i.e. genetic sequence data, DNA data and identification data, and resulting data is analyzed by computing systems comprising non-volatile memory and storage.
However, Yun et al. do not expressly teach claim 18.
Prior to the effective filing date of the claimed invention, like Yun et al., Yun II teach systems comprising coated particles. Furthermore, Yun II teach particles are known in the art that are coated with biocompatible molecules such as antibodies ( e.g. Entire Yun reference and especially para 0245,para 0247, pg. 19).
Therefore, it would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date to modify the teachings of Yun et al. to include the teaching of Riggio as a person of ordinary skill in the art would recognize that these claim elements were known in the art and one of skill in the art could have combined these elements by known methods with no change in their respective functions, and the combination would have yielded the predictable outcome of the claimed invention.
Therefore, the combined teachings of Yun and Yun II render obvious claim 18.
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.
U.S. Patent No. 10,707,649
Claims 1-15 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-33 of U.S. Patent No. 10,707,649 in view of Yun et al.(WO2020086510); Kwok et al. ("Multiplexed laser particles for spatially resolved single-cell analysis." Light: Science & Applications 8.1 (2019): 74; 5 pages; published online 21 August 2019); Zhu et al.( "Poly (l‐lysine)‐modified silica nanoparticles for the delivery of antisense oligonucleotides." Biotechnology and applied biochemistry 39.2 (2004): 179-187); Riggio et al. (""Poly-l-lysine-coated magnetic nanoparticles as intracellular actuators for neural guidance." International journal of nanomedicine (2012): 3155-3166.) and Yun et al. (US20190296521), i.e. Yun II.
Claims 1-33 of U.S. Patent No. 10,707,649 teach several limitations similar to the instant invention, including laser particles coated with nucleic acids.
However, claims 1-33 of U.S. Patent No. 10,707,649 do not expressly teach all the features of the claimed invention, such as systems comprising particles that are less than 3 mm.
However, these features are known in the art. As noted in the current rejections, Yun et al. teach claims 1, 2, 4-9 and 11-13. Furthermore, the additional teachings of Kwok et al. render obvious claim 3. Furthermore, the additional teachings of Zhu et al. render obvious claims 16 and 17.Furthermore, the additional teachings of Riggio et al. render obvious claims 16, 17 and 19. Furthermore, the additional teachings of Yun II render obvious claim 18.
Therefore, as claims 1-33 of U.S. Patent No. 10,707,649, Yun et al., Kwok et al., Riggio et al. and Yun II all disclose methods comprising systems comprising laser particles for optical tagging of single cells, it would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date to modify the method of claims 1-33 of U.S. Patent No. 10,707,649 and to include the teachings of Yun et al., Kwok et al., Zhu et al., Riggio et al. and Yun II as discussed in the rejections above because a person of ordinary skill in the art would recognize that these claim elements were known in the art and one of skill in the art could have combined these elements by known methods with no change in their respective functions, and the combination would have yielded the predictable outcome of providing systems comprising laser particles for optical tagging of single cells.
Response to the Arguments
Any rejection not reiterated or specifically addressed has been overcome by amendment. New rejections are set forth to address the amended claims.
However, previously cited references teach art relevant to the amended claims and therefore are included in the new rejections.
Regarding Applicants’ arguments that the previously cited art does not meet the requirements of the amended claims: these arguments are not persuasive.
As discussed in the current rejections, Yun et al. teach particles comprising a coating that is distinct from the coded oligonucleotides. Furthermore, due to claim amendments, new art is applied to meet the requirements of the instant claims.
Conclusion
No claims are allowable.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SAHANA S KAUP whose telephone number is (571)272-6897. The examiner can normally be reached on M-F 7-10 EST.
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/SAHANA S KAUP/Supervisory Primary Examiner, Art Unit 1612
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