DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 06/27/2025 has been entered.
Priority
The present application was filed on 12/23/2021. This application claims benefit of U.S. Provisional Patent Application 63/130,857 filed on 12/28/2020 and 63/194,188 filed on 05/28/2021.
Claim status
Claim 5 is canceled. Claims 1 and 14 are amended. Claims 1-4 and 6-15 are pending and examined herein.
Withdrawn Objections/Rejections
The rejection of claims 1-4 and 6-15 under 35 USC 103 as being unpatentable over Koliha in view of Chen-598 and Chen-195 and Matsumoto is withdrawn in view of Applicant’s arguments filed on 06/27/2025.
New grounds rejection is made in view of Applicant’s arguments and as necessitate to the amendment
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.
Claim(s) 1-4, and 6-12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Koliha et al. (A novel multiplex bead-based platform highlights the diversity of extracellular vesicles, Journal of Extracellular Vesicles 2016, 5: 29975, PTO-892 08/20/24) in view of Chen et al. (PGPub 20190206598, herein Chen-598, PTO-892 08/20/24), Chen et al. (PGPub 20190203195, herein Chen-195, PTO-892 08/20/24).
Regarding claim 1, Koliha discloses a detection method of multiple analytes (see Abstract: teaching a multiplex immunoassay for detecting 39 different surface markers in a sample simultaneously; and Fig.1: teaching that EVs bound to the beads were detected with single antibody (such as anti-CD9, anti-CD63, anti-CD81) or with a cocktail of the said 3 antibodies above).
Also, the method comprises a microparticle coupled with one first ligand (see Abstract and page 3 left col par.2: teaching that a capture antibody is captured on the bead; the antibody is against one of surface markers; extracellular vesicle (EV) is an analyte of the assay).
The method further comprises mixing the microparticle with a specimen comprising a variety of analytes to form a first complex; mixing the first complex with a variety of second ligands carrying a variety of first labels, such that the variety of second ligands bind to the variety of analytes in the first complex and form a second complex; and detecting the variety of first labels in the second complex. See section 2.4 and Fig.1: showing that the first complex is between capture Ab-bead and EV, the second complex is capturing Ab-bead – EV and antibody labeled with APC. Also, a variety of Ab-APCs is used in the assay.
However, Koliha does not teach the bead (i.e., microparticle) comprising a body and a plurality of first protrusions formed on a surface of the body, wherein the plurality of first protrusions and the body are integrally formed and seamlessly connected. Koliha does not teach that the claimed ratio of an average volume of the protrusion to an average volume of the body is 1x10-7 to 2x10-2 and a total volume of the protrusions to an overall volume of the microparticle is 1x10-1 to 6x10-1.
Chen-598 teaches a magnetic particle having a copolymer core and a plurality of protrusions on the surface of the body (see par. 41 and Fig.1: teaching that the surface of the magnetic substance layer may have small protrusions or rough surface, which thereby reads on the first protrusions). Chen-598 teaches that the particle is wildly used in the field of biomedicine such as in immune-quantitative analysis (see Abstract and par.3), purification and separation, or cell stimulation and amplification (see par.64).
Chen-598 discloses the manufacturing method of the magnetic particle. First, polymerizing at least two monomers into a copolymer is performed to form a knobby copolymer core. Next, forming a polymer layer to cover the knobby copolymer core is performed, in which the polymer layer has at least one functional group. Thereafter, adsorbing a magnetic substance precursor is performed by the knobby copolymer core covered with the polymer layer to form a magnetic substance layer. Further, a silicon-based layer may be additionally formed to cover the magnetic substance layer. See par.19.
This teaching of Chen-598 is comparable with the disclosure of the claimed particle in the instant specification (see par.8: the body of the knobby particle includes a copolymer core, a polymer layer, and a silicon-based layer from the inside to the outside), thus it appears that the particle of Chen-598 is also integrally formed and seamlessly connected.
For the claimed ratio of an average volume of the protrusion to an average volume of the body is 1x10-7 to 2x10-2 and a total volume of the protrusions to an overall volume of the microparticle is 1x10-1 to 6x10-1, it can be interpreted as the size of the protrusion relatively to the size of the body of the particle, and the size of the protrusion relatively to the size of the whole particle.
Chen-598 further provides the average diameter of the particle and average height of the protrusion (see par.35-36), whereas the average diameter of the knobby copolymer core and the average height h of the protrusions are also disclosed (see par.55-57). While Chen-598 does not specifically teach the same claimed ratio, one having ordinary skills in the art can calculate that ratio based on the range of diameter of the protrusion, the core and the particle as taught by Chen-598. Absent unexpected results, it would have been obvious for one of ordinary skill to discover the optimum workable ranges of the volume ratio by normal optimization procedures known in the art. The motivation to do so is that the surface area of the magnetic particle can be greatly increased, thereby contributing to the close packing of the magnetic particles (see par.64).
Chen-195 provides a method for in vitro activation and/or expansion of immune cells (see Abstract). The method comprises providing magnetic particle having a copolymer core and a plurality of protrusions (see Abstract). On the surface of the particle, there is at least one type of immune-inducing substance, e.g., antibody (see at least par. 9, 17 and 35), which assists the contacting of the magnetic particle with the immune cells (see at least Abstract and par.27). This teaching indicates that the magnetic particle with protrusions can bind to a target via a ligand on its surface, and thereby it anticipates the claimed particle.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method taught by Koliha, substituting the capture bead with the particle taught by Chen-598 because the knobby surface particle would provide larger surface area and conform to the biomimetic concept simultaneously in compared with the equal volume sphere particle (see par.3-4). Moreover, the knobby polymer particle can adsorb more magnetic substance precursors to achieve the effect of high magnetic quantization (see par.26). Also, Chen-598 teaches that the particle is wildly used in the field of biomedicine such as in immune-quantitative analysis (see Abstract and par.3) and Chen-195 proves that the multi-protrusion particle coupled with a ligand on its surface can bind to a target (see Abstract and par.35). Therefore, the multi-protrusion particle taught by Chen is functional equivalent with the capture bead taught by Koliha. One having ordinary skills in the art would have had a reasonable expectation of success in using the particle taught by Chen-195 because Chen -598 teaches the particle may be used in immune-quantitative analysis, i.e., multiplex cytokine measurement.
Regarding claims 2-3, Koliha, Chen-598 and Chen-195 teach the invention as discussed above. Koliha doesn’t teach the structure of the microparticle. However, Chen-598 discloses that the particle has a knobby copolymer core, a polymer layer, a magnetic substance layer and a silicon-based layer from the inside to the outside (see Par.34 and Fig.1). Fig.1 shows that there is a plurality of protrusions formed on a surface of the copolymer core 110 (see Fig.1 and par.34). The average height of the plurality of protrusions is 100 nm to 5000 nm (see par.8).
Regarding claim 4, Koliha, Chen-598 and Chen-195 teach the invention as discussed above. Koliha fails to teach the ratio of an average height of the first protrusions to an average diameter of the body is 0.005 to 0.25.
However, Chen-598 discloses that the average diameter D and the average height of the core protrusions are 4.5um:1000nm (see par.55), or 2.5um:500nm (see par.57), or 8.5um:900nm (see par.59). So the ratio may range from 0.1-0.22.
Chen further shows that the polymer layer 120, the magnetic substance layer 130, and the silicon-based layer 140 sequentially formed on the knobby copolymer core 110 do not substantially change the morphology of the knobby copolymer core 110, the resulting magnetic particles 100 still have knobby appearance (see par.43), and therefore it appears that the ratio of average diameter D and the average height of the core protrusions is similar to the ratio of average diameter D and the average height of the surface protrusions. Therefore, this teaching anticipates the claim.
While Chen does not specifically teach the same height of the protrusion of the particle, as the same ratio of an average height of the protrusion to an average diameter of the particle body, they do suggest varying the height of the protrusion attached on the surface of the particle. It has long been settled to be no more than routine experimentation for one of ordinary skill in the art to discover an optimum value of an average height of the surface protrusion on the surface of an particle.
Since Applicant has not disclosed that the specific limitations recited in instant claim 4 (the ratio of the height of the protrusion and the diameter of the particle) is for any particular purpose or solve any stated problem and the prior art teaches that limitation often varies, absent unexpected results, it would have been obvious for one of ordinary skill to discover the optimum workable ranges of the height of the protrusion or the claimed ratio by normal optimization procedures known in the art.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method taught by Koliha, substituting the capture bead with the particle taught by Chen-598. It is because Chen-598 teaches that the particle is wildly used in the field of biomedicine such as in immune-quantitative analysis (see Abstract and par.3) and Chen-195 proves that the multi-protrusion particle coupled with a ligand on its surface can bind to a target. Therefore, the multi-protrusion particle taught by Chen is functional equivalent with the capture bead taught by Koliha. One having ordinary skills in the art would have had a reasonable expectation of success in using the particle taught by Chen-195 because Chen -598 teaches the particle may be used in immune-quantitative analysis, i.e., multiplex cytokine measurement.
Regarding claim 6, Koliha, Chen-598 and Chen-195 teach the invention as discussed above. Koliha fails to teach that an average number of the first protrusions is 5 to 500, and an average diameter of the microparticle is 1 μm to 20 μm.
However, Chen-598 teaches that the average diameter of the microparticle may be from 4-20 um (see par.35). Chen-598 also discloses that a range of an average diameter is greater than 1 um; particularly, it may range from 1-50um or 2-40um or 3-30um (see par.35). Thus this teaching anticipates the claimed average diameter of the particle.
Chen-598 also discloses the particle has a plurality of protrusions on its surface (see par.8 and par.34).
While Chen does not specifically teach the same claimed number of the first protrusions and the same claimed diameter of the microparticle, they do suggest varying values of diameter of the microparticle and a plurality number of the protrusion attached on the surface of the particle.
It has long been settled to be no more than routine experimentation for one of ordinary skill in the art to discover an optimum value of a result effective variable.
Since Applicant has not disclosed that the specific limitations recited in instant claim 6 (the number of the protrusion on the particle and the average diameter of the microparticle) is for any particular purpose or solve any stated problem and the prior art Chen provides the microparticle having compatible structural and functional properties of the claimed particle, absent unexpected results, it would have been obvious for one of ordinary skill to discover the optimum workable ranges of the number of the protrusion and the average diameter of the microparticle by normal optimization procedures known in the art.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method taught by Koliha, substituting the capture bead with the particle taught by Chen-598. It is because Chen-598 teaches that the particle is wildly used in the field of biomedicine such as in immune-quantitative analysis (see Abstract and par.3) and Chen-195 proves that the multi-protrusion particle coupled with a ligand on its surface can bind to a target. Therefore, the multi-protrusion particle taught by Chen is functional equivalent with the capture bead taught by Koliha. One having ordinary skills in the art would have had a reasonable expectation of success in using the particle taught by Chen-195 because Chen -598 teaches the particle may be used in immune-quantitative analysis, i.e., multiplex cytokine measurement.
Regarding claim 7, Koliha, Chen-598 and Chen-195 teach the invention as discussed above. Koliha doesn’t teach that the particle is non-spherical. However, Chen-598 teaches that the particle may have a rough surface which provides larger surface area and conforms to the biomimetic concept simultaneously (see par.3-4 and 41), thus, Chen-598 teaches non-spherical particles.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method taught by Koliha, substituting the capture bead with the particle taught by Chen-598 because the non-spherical, knobby surface particle would provide larger surface area and conform to the biomimetic concept simultaneously in compared with the equal volume sphere particle (see par.3-4). Moreover, the knobby polymer particle can adsorb more magnetic substance precursors to achieve the effect of high magnetic quantization (see par.26). Also, Chen-598 teaches that the particle is wildly used in the field of biomedicine such as in immune-quantitative analysis (see Abstract and par.3) and Chen-195 proves that the multi-protrusion particle coupled with a ligand on its surface can bind to a target (see Abstract and par.35). One having ordinary skills in the art would have had a reasonable expectation of success in using the particle taught by Chen-195 because Chen -598 teaches the particle may be used in immune-quantitative analysis, i.e., multiplex cytokine measurement.
Regarding claims 8-12, Koliha, Chen-598 and Chen-195 teach the invention as discussed above. Koliha discloses an immunoassay for extracellular vesicles (EVs) involving microparticles bearing capture antibodies and a plurality of detection labeled antibodies (see page 3 left col par.2 and 4, Fig.1). The detection labeled antibody and the capture antibody are from the same clones (see page 3 left col par.4). For example, they are antibodies to cell specific markers or exosome markers such as anti-CD9-APC, anti-CD63-APC, anti-CD81-APC antibodies. Since the antibodies are to the surface antigen on the exosome, the teaching anticipates the claims 8 and 11.
From the teaching above, Koliha provides that there are a variety of analytes (i.e., CD9, CD63 or CD81 markers) located on a surface of the exosome (i.e., EVs) (see page 5 left col par.2). The teaching also anticipates the limitation that the first complex is formed between capture Ab-bead and exosome via the specific binding between antibodies to the marker on the surface of exosome. The exosome can be derived from human (see page 2 right col). Thus, the teaching anticipates claims 9 and 10.
Moreover, Fig.1 teaches that EVs bound to the beads were detected with single antibody (such as anti-CD9, anti-CD63, anti-CD81) or with a cocktail of the said 3 antibodies above. Thus, the first ligand can comprise a variety of first ligands that the capture Ab-beads can bind to. Thus, the teaching anticipates claim 12.
Claim(s) 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Koliha et al. (A novel multiplex bead-based platform highlights the diversity of extracellular vesicles, Journal of Extracellular Vesicles 2016, 5: 29975) in view of Chen et al. (PGPub 20190206598, herein Chen-598) and Chen et al. (PGPub 20190203195, herein Chen-195), as applied to claim 1 above, and further in view of Natan et al. (PGPub 20020146745, PTO-892 08/20/24).
Regarding claim 13, Koliha, Chen-598 and Chen-195 teach the invention as discussed above. Koliha fails to teach that the first ligand can be nucleic acid probes that can bind to nucleic acid sequences carrying a label, wherein a label comprises antigenic epitopes.
Natan discloses a multiplexed analyte analysis method using particles bearing an oligonucleotide, e.g., nucleic acid probe (see par.30) to interact with fluorescently-labeled DNA, e.g., analyte with label (see par.58). Natan further teaches that the analyte may include viral epitopes (see par.33). Therefore, the teaching of Natan anticipates the claim.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method taught by Koliha, coupling a nucleic acid probe on to the particle to detect a nucleic acid sequences analyte, wherein the analyte is conjugated with label and antigenic epitope as taught by Natan. The motivation to do so is that Natan provides the advantages of solution-based capture probes and surface-bound capture arrays, which gives a flexible method for detecting analytes at a wide range of concentrations in complex biological samples. See par.15.
One having ordinary skill in the art would have had a reasonable expectation of success in combining Koliha and Natan because they are both directed to multiplexed assays that use particles bearing ligand to detect a plurality of analytes of interest.
Claim(s) 14-15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Natan et al. (PGPub 20020146745, PTO-892 08/20/24) in view of Chen et al. (PGPub 20190206598, herein Chen-598, PTO-892 08/20/24) and Chen et al. (PGPub 20190203195, herein Chen-195, PTO-892 08/20/24).
Regarding claims 14-15, Natan discloses a multiplexed analyte analysis method using particles bearing a variety of ligands (see Abstract, Fig.2: showing a capture bead with multiple types of ligands).
Natan also mixes the particle with a sample containing analytes of interest to form a complex (see Abstract);
wherein the analytes carry a variety of labels (see par.58: teaching that the use of two fluorophores with different emission characteristics verifies attachment of both molecules);
and detects the labels in the complex (see Abstract, par.4: teaching that detection of bound analyte is enabled by radioactive or fluorescent tags bound to the analyte).
In par.58, Natan indicates that the ligands can be nucleic acid probes, the label is fluorescent and the analytes is nucleic acid sequences. Thus, the teaching anticipates claim 15.
However, Natan fails to teach the bead (i.e., microparticle) comprising a body and a plurality of first protrusions formed on a surface of the body.
Chen-598 teaches a magnetic particle having a copolymer core and a plurality of protrusions on the surface of the body (see par. 41 and Fig.1: teaching that the surface of the magnetic substance layer may have small protrusions or rough surface, which thereby reads on the first protrusions). Chen-598 teaches that the particle is wildly used in the field of biomedicine such as in immune-quantitative analysis (see Abstract and par.3).
Chen-598 discloses the manufacturing method of the magnetic particle. First, polymerizing at least two monomers into a copolymer is performed to form a knobby copolymer core. Next, forming a polymer layer to cover the knobby copolymer core is performed, in which the polymer layer has at least one functional group. Thereafter, adsorbing a magnetic substance precursor is performed by the knobby copolymer core covered with the polymer layer to form a magnetic substance layer. Further, a silicon-based layer may be additionally formed to cover the magnetic substance layer. See par.19.
This teaching of Chen-598 is comparable with the disclosure of the claimed particle in the instant specification (see par.8: the body of the knobby particle includes a copolymer core, a polymer layer, and a silicon-based layer from the inside to the outside), thus it appears that the particle of Chen-598 is also integrally formed and seamlessly connected.
Chen-195 provides a method for in vitro activation and/or expansion of immune cells (see Abstract). The method comprises providing magnetic particle having a copolymer core and a plurality of protrusions (see Abstract). On the surface of the particle, there is at least one type of immune-inducing substance, e.g., antibody (see at least par. 9, 17 and 35), which assists the contacting of the magnetic particle with the immune cells (see at least Abstract and par.27) This teaching indicates that the magnetic particle with protrusions can bind to a target via a ligand on its surface, which thereby anticipates the claimed particle.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method taught by Natan, substituting the capture bead with the particle taught by Chen-598 because the knobby surface particle would provide larger surface area and conform to the biomimetic concept simultaneously in compared with the equal volume sphere particle (see par.3-4). Moreover, the knobby polymer particle can adsorb more magnetic substance precursors to achieve the effect of high magnetic quantization (see par.26). Also, Chen-598 teaches that the particle is wildly used in the field of biomedicine such as in immune-quantitative analysis (see Abstract and par.3) and Chen-195 proves that the multi-protrusion particle coupled with a ligand on its surface can bind to a target (see Abstract and par.35). Therefore, the multi-protrusion particle taught by Chen is functional equivalent with the capture bead taught by Natan. One having ordinary skills in the art would have had a reasonable expectation of success in using the particle taught by Chen teaches the particle may be used in immune-quantitative analysis, i.e., multiplex cytokine measurement.
Response to Arguments
Applicant's arguments filed 06/27/2025 have been fully considered but they are not persuasive.
Applicant argues that a person skilled in the art could not possibly adjust the number and density of the protrusions on the body of particles in Chen-598 through the teachings of Matsumoto. However, the argument regarding the Matsumoto is moot because the reference has been withdrawn from the rejection.
Applicant argues that the teachings of Koliha, Chen-598 and Chen-195 and Natan fail to teach the limitations of the amended claims 1 and 14 “the first protrusions and the body are integrally formed and seamlessly connected” and “a ratio of an average volume of the first protrusions to an average volume of the body is 1x10-7 to 2x10-2, and a total volume of the first protrusions to an overall volume of the microparticle is 1x10-1 to 6x10-1”.
However, this argument is not persuasive because Chen-598 discloses the manufacturing method of the magnetic particle. First, polymerizing at least two monomers into a copolymer is performed to form a knobby copolymer core. Next, forming a polymer layer to cover the knobby copolymer core is performed, in which the polymer layer has at least one functional group. Thereafter, adsorbing a magnetic substance precursor is performed by the knobby copolymer core covered with the polymer layer to form a magnetic substance layer. Further, a silicon-based layer may be additionally formed to cover the magnetic substance layer. See par.19.
This teaching of Chen-598 is comparable with the disclosure of the claimed particle in the instant specification (see par.8: the body of the knobby particle includes a copolymer core, a polymer layer, and a silicon-based layer from the inside to the outside), thus it appears that the particle of Chen-598 is also integrally formed and seamlessly connected.
For the claimed ratio of an average volume of the protrusion to an average volume of the body is 1x10-7 to 2x10-2 and a total volume of the protrusions to an overall volume of the microparticle is 1x10-1 to 6x10-1, it can be interpreted as the size of the protrusion relatively to the size of the body of the particle, and the size of the protrusion relatively to the size of the whole particle.
Chen-598 further provides the average diameter of the particle and average height of the protrusion (see par.35-36), whereas the average diameter of the knobby copolymer core and the average height h of the protrusions are also disclosed (see par.55-57). While Chen-598 does not specifically teach the same claimed ratio, one having ordinary skills in the art can calculate that ratio based on the range of diameter of the protrusion, the core and the particle as taught by Chen-598. Absent unexpected results, it would have been obvious for one of ordinary skill to discover the optimum workable ranges of the volume ratio by normal optimization procedures known in the art. The motivation to do so is that the surface area of the magnetic particle can be greatly increased, thereby contributing to the close packing of the magnetic particles (see par.64).
Chen-195 provides a method for in vitro activation and/or expansion of immune cells (see Abstract). The method comprises providing magnetic particle having a copolymer core and a plurality of protrusions (see Abstract). On the surface of the particle, there is at least one type of immune-inducing substance, e.g., antibody (see at least par. 9, 17 and 35), which assists the contacting of the magnetic particle with the immune cells (see at least Abstract and par.27). This teaching indicates that the magnetic particle with protrusions can bind to a target via a ligand on its surface, and thereby it anticipates the claimed particle.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method taught by Koliha, substituting the capture bead with the particle taught by Chen-598 because the knobby surface particle would provide larger surface area and conform to the biomimetic concept simultaneously in compared with the equal volume sphere particle (see par.3-4). Moreover, the knobby polymer particle can adsorb more magnetic substance precursors to achieve the effect of high magnetic quantization (see par.26). Also, Chen-598 teaches that the particle is wildly used in the field of biomedicine such as in immune-quantitative analysis (see Abstract and par.3) and Chen-195 proves that the multi-protrusion particle coupled with a ligand on its surface can bind to a target (see Abstract and par.35). Therefore, the multi-protrusion particle taught by Chen is functional equivalent with the capture bead taught by Koliha. One having ordinary skills in the art would have had a reasonable expectation of success in using the particle taught by Chen-195 because Chen -598 teaches the particle may be used in immune-quantitative analysis, i.e., multiplex cytokine measurement.
Therefore, the claimed microparticle does not exhibit an unexpected effects as argued by the Applicant in the Remarks.
Conclusion
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/CHAU N.B. TRAN/Examiner, Art Unit 1677
/BAO-THUY L NGUYEN/Supervisory Patent Examiner, Art Unit 1677 August 12, 2025
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