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 .
Information Disclosure Statement
The Examiner acknowledges receipt of the lengthy information disclosure statement filed 04/25/2024. There is no requirement that applicants explain the materiality of English language references, however the cloaking of a clearly relevant reference in a long list of references may not comply with applicants’ duty to disclose, see Penn Yan Boats, Inc. v. Sea Lark Boats, Inc., 359 F. Supp. 948, aff’d 479 F. 2d. 1338. There is no duty for the Examiner to consider these references to a greater extent than those ordinarily looked at during a regular search by the Examiner. Accordingly, the Examiner has considered these references in the same manner as references encountered during a normal search of Office search files.
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.
Claims 1-3, 8-9 and 11 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Siddiqui et al. (WO 2022232610 A2, as cited by the IDS).
Regarding claim 1, Siddiqui et al. teaches a method for fractionating a biological sample comprising a plurality of biomolecules (see Abstract, disclosing methods for enriching subsets of complex biological samples, further providing methods for utilizing functionalized particles for subsets of biomolecules to fractionate and analyze the complex biological samples.), the method comprising: a) contacting the biological sample with a plurality of particles, thereby adsorbing the plurality of biomolecules to surfaces of the plurality of particles to form at least one biomolecule corona on the plurality of particles (see [0070], [00150], [00291], disclosing contacting a biological sample with a surface to bind a plurality of biomolecules to a peptide coupled to the surface, where a collection of biomolecules adsorbed on the surface of a particle may be referred to as a 'biomolecule corona'.); b) separating at least one particle comprising a biomolecule corona from the plurality of particles to form a first fraction, wherein separating of the first fraction is based on a physicochemical property of the first fraction, wherein the at least one particle comprising the biomolecule corona in the first fraction comprises a first subset of the plurality of biomolecules of the biological sample (see [00314], disclosing the particles being used to serially interrogate a sample by incubating a first particle type with the sample to form a biomolecule corona on the first particle type. Each of the plurality of particle types may be separated from a biological sample or mixture of particles based on their physical, chemical, charge, or magnetic properties. Additionally see [00174], disclosing contacting said sample with a composition comprising a first surface-modified particle configured to enrich for a first subset of proteins in said sample.); c) desorbing the first subset of the plurality of biomolecules of the biological sample in the first fraction (see [00362], disclosing desorbing, from the one or more surface regions, at least a portion of the set of adsorbed biomolecules to yield the set of proteins.); d) separating at least one particle comprising a biomolecule corona from the remaining plurality of particles in step (b) to form a second fraction, wherein separating of the second fraction is based on a physicochemical property of the second fraction, wherein the at least one particle comprising the biomolecule corona in the second fraction comprises a second subset of the plurality of biomolecules of the biological sample (see [00314], disclosing the particles being used to serially interrogate a sample by incubating a second particle type with the sample to form a biomolecule corona on the second particle type. Each of the plurality of particle types may be separated from a biological sample or mixture of particles based on their physical, chemical, charge, or magnetic properties. Additionally see [00174], disclosing contacting said sample with a composition comprising a second surface-modified particle configured to enrich for a second subset of proteins in said sample.); e) desorbing the second subset of the plurality of biomolecules of the biological sample in the second fraction (see [00362], disclosing desorbing, from the one or more surface regions, at least a portion of the set of adsorbed biomolecules to yield the set of proteins.); and f) collecting the desorbed first and second subsets of the plurality of biomolecules, thereby fractionating the biological sample (see [00367], disclosing the collected biomolecule corona or the collected subset of biomolecules from the biomolecule corona may be purified or fractionated (e.g., by a chromatographic method).).
Regarding claim 2, Siddiqui et al. teaches the method of claim 1, wherein the plurality of particles comprises at least two subsets of particles, each subset of particles differing by at least one physicochemical property see [00314], [00356], disclosing a first and second particle type, where the different particles may be distinct particle types, such that each particle differs from the other particles my at least one physicochemical property, leading to the formation of different protein corona compositions on the particle surfaces.).
Regarding claim 3, Siddiqui et al. teaches the method of claim 2, wherein the physicochemical property is selected from the group consisting of composition, size, surface charge, hydrophobicity, hydrophilicity, roughness, density surface functionalization, surface topography, surface curvature, porosity, core material, shell material, shape, zeta potential, and any combination thereof (see [0090], [00308], disclosing particles may differ from one or more physiochemical properties, selected from the group consisting of composition, size, surface charge, hydrophobicity, hydrophilicity, roughness, density surface functionalization, surface topography, surface curvature, porosity, core material, shell material, shape, and any combination thereof. Additionally, the particle surface may additionally comprise a surface zeta potential.).
Regarding claim 8, Siddiqui et al. teaches the method of claim 1, wherein contacting the biological sample with a plurality of particles, thereby adsorbing the plurality of biomolecules comprising at least 3, at least 4, at least 5, at least 10, at least 20, at least 35, at least 50, at least 70, or at least 90 different protein groups to surfaces of the plurality of particles (see [00235], [00261], [00346], Fig. 17, dislcosing compositions, systems, and methods for collecting biomolecules on surfaces, porous materials, particles, surface panels and particle panels of multiple distinct surface or particle types, which enrich proteins from a sample. A particle panel including any number of distinct particle types, enriches and identifies a single protein or protein group. In Figure 17., the number of protein groups is identified using particles, ranging from up to 600 protein groups.).
Regarding claim 9, Siddiqui et al. teaches the method of claim 1, wherein contacting the biological sample with a plurality of particles, thereby adsorbing the plurality of biomolecules comprising at least 100, at least 150, at least 200, at least 250, at least 300, at least 400, at least 500, at least 750, or at least 900 different protein groups to surfaces of the plurality of particles (see [00235], [00261], [00346], Fig. 17, disclosing compositions, systems, and methods for collecting biomolecules on surfaces, porous materials, particles, surface panels and particle panels of multiple distinct surface or particle types, which enrich proteins from a sample. A particle panel including any number of distinct particle types, enriches and identifies a single protein or protein group. In Figure 17., the number of protein groups is identified using particles, ranging from up to 600 protein groups.).
Regarding claim 11, Siddiqui et al. teaches the method of claim 1, wherein desorbing the subset of the plurality of biomolecules of the biological sample from the particle comprises treating the particle with an enzyme selected from the group consisting of trypsin, chymotrypsin, endoproteinase Glu C, endoproteinase Lys C, elastase, subtilisin, proteinase K, thrombin, factor X, endoproteinase Arg C, papain, endoproteinase AspN, thermolysin, pepsin, aspartyl protease, cathepsin D, zinc mealloprotease, glycoprotein endopeptidase, aminopeptidase, prenyl protease, caspase, kex2 endoprotease, or any combination thereof (see [0153], [0192], disclosing the plurality of biomolecules comprises at least one target biomolecule in the at least three different target biomolecules; such that: the peptide binds to the at least one target biomolecule in the at least three different target biomolecules; and the plurality of biomolecules adsorbs on the surface; contacting the surface with a proteolytic enzyme to release: the at least one target biomolecule; at least a subset of the plurality of biomolecules adsorbed on the surface; and at least a portion of the peptide; thereby producing a second composition. The proteolytic enzyme is trypsin or lysin.).
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 4-5 and 7 are rejected under 35 U.S.C. 103 as being unpatentable over Siddiqui et al. as applied to claims 2 and 3 above, and further in view of Andreescu et al. (US PG-Pub 20180022604 A1, as cited in the IDS).
Regarding claim 4, Siddiqui et al. fails to teach wherein the adsorption of the plurality of biomolecules to the surface of the plurality of particles results in a change of a physicochemical property.
However, in the analogous art of functional platform for rapid capture and removal of nanoparticles, Andreescu et al. teaches having catechol (i.e., a biomolecule) adsorbed onto CeO2 nanoparticles, where weight loss and size decrease was observed. Additional evidence of this phenomenon is provided by the change in the zeta potential value, which decreased from ~+40.4 mV (CeO2 NPs) to ~+19.5 mV for catechol-CeO2 NPs, as shown in Fig. 6B (see Andreescu et al., [0066], Fig. 6B).
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 adsorption of a plurality of biomolecules onto a plurality of particles of Siddiqui et al. to incorporate the adsorption resulting in a change in physicochemical properties, such as size and zeta potential changing (as taught by Andreescu et al.), for the benefit of re-evaluating particle property following adsorbing biomolecules to assay the effects of adsorption, especially when utilizing the method of Andreescu et al. in inexpensively screening large number of samples for NP presence and separation (see Andreescu et al., [0054], [0066]).
Regarding claim 5, Siddiqui et al. fails to teach wherein the adsorption results in a change in zeta potentials of the particles.
However, Andreescu et al. teaches having catechol (i.e., a biomolecule) adsorbed onto CeO2 nanoparticles, where weight loss and size decrease was observed. Additional evidence of this phenomenon is provided by the change in the zeta potential value, which decreased from ~+40.4 mV (CeO2 NPs) to ~+19.5 mV for catechol-CeO2 NPs, as shown in Fig. 6B (see Andreescu et al., [0066], Fig. 6B).
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 adsorption of a plurality of biomolecules onto a plurality of particles of Siddiqui et al. to incorporate the adsorption resulting in a change in zeta potential in the particles (as taught by Andreescu et al.), for the benefit of re-evaluating particle property following adsorbing biomolecules to assay the effects of adsorption, especially when utilizing the method of Andreescu et al. in inexpensively screening large number of samples for NP presence and separation (see Andreescu et al., [0054], [0066]).
Regarding claim 7, Siddiqui et al. fails to teach wherein the adsorption of biomolecules decreases the zeta potentials of the particles.
However, Andreescu et al. teaches having catechol (i.e., a biomolecule) adsorbed onto CeO2 nanoparticles, where weight loss and size decrease was observed. Additional evidence of this phenomenon is provided by the change in the zeta potential value, which decreased from ~+40.4 mV (CeO2 NPs) to ~+19.5 mV for catechol-CeO2 NPs, as shown in Fig. 6B (see Andreescu et al., [0066], Fig. 6B).
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 adsorption of a plurality of biomolecules onto a plurality of particles of Siddiqui et al. to incorporate the adsorption resulting in a decrease in zeta potential in the particles (as taught by Andreescu et al.), for the benefit of re-evaluating particle property following adsorbing biomolecules to assay the effects of adsorption, especially when utilizing the method of Andreescu et al. in inexpensively screening large number of samples for NP presence and separation (see Andreescu et al., [0054], [0066]).
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Siddiqui et al. as applied to claim 2 above, and further in view of Bravo-Osuna et al. ("Tuning of shell and core characteristics of chitosan-decorated acrylic nanoparticles").
Regarding claim 6, Siddiqui et al. fails to teach wherein the adsorption of biomolecules increases the zeta potentials of the particles.
However, in the analogous art of "Tuning of shell and core characteristics of chitosan-decorated acrylic nanoparticles", Bravo-Osuna et al. teaches surface modified nanoparticles comprising chitosan-coating of acrylic nanoparticles for increasing specificity of absorption of drugs associated given by the mucosal route. Changes in shell composition were noted when applying chitosan of differing molecular weights, as seen in Table 3-4, where both the particle size and the surface charge (i.e., zeta surface potential) increases with higher amounts of chitosan molecular weights being applied to the surface of the nanoparticle (see Bravo-Osuna et al., Abstract, pg. 143 1. Introduction, Table 3-4).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify adsorption of a plurality of biomolecules onto a plurality of particles of Siddiqui et al. to incorporate the adsorption of biomolecules resulting in an increase in zeta potential in the particle (as taught by Bravo-Osuna et al.), for the benefit of in vitro and in vivo evaluation of particle systems following adsorption of biomolecules, to ascertain the physiochemical changes such as surface charge (see Bravo-Osuna et al., Abstract).
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Siddiqui et al.
Regarding claim 10, Siddiqui et al. teaches disclosing compositions, systems, and methods for collecting biomolecules on surfaces, porous materials, particles, surface panels and particle panels of multiple distinct surface or particle types, which enrich proteins from a sample. A particle panel including any number of distinct particle types, enriches and identifies a single protein or protein group. In Figure 17., the number of protein groups is identified using particles, ranging from up to 600 protein groups (see Siddiqui et al., [00235], [00261], [00346], Fig. 17).
While Siddiqui et al. doesn't explicitly teach the plurality of biomolecules comprising at least 1000, 1500, at least 2000, at least 5000, at least 10000, at least 20000, at least 20000, at least 50000, or at least 100000 different protein groups to surfaces of the plurality of particles, it would have been obvious to one of ordinary skill to utilize the plurality of biomolecules comprising at least 1000, 1500, at least 2000, at least 5000, at least 10000, at least 20000, at least 20000, at least 50000, or at least 100000 different protein groups to surfaces of the plurality of particles as a result of routine optimization (See MPEP 2144.05 regarding routine optimization; see also In reAller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) ("[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation"); see also Peterson, 315 F.3d at 1330, 65 USPQ2d at 1382 (Fed. Cir. 2003) ("The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set of percentage ranges is the optimum combination of percentages.").
Claims 12-20 are rejected under 35 U.S.C. 103 as being unpatentable over Siddiqui et al., in further in view of Manning et al. (US PAT 11630112 B2, as cited in the IDS).
Regarding claim 12, Siddiqui et al. teaches methods for fractionating, collecting, enriching and depleting biomolecules from complex biological samples. This is done by collecting biomolecules following contact of a biological sample surfaces such as particle panels, where they may form distinct biomolecule coronas on the surfaces of the distinct particle types. The particle panels can be used in methods of corona analysis to detect thousands of proteins across a wide dynamic range. (see Siddiqui et al., [00260]-[00261]).
Siddiqui et al. fails to teach b) contacting the one or more particles with a first solution, thereby desorbing a first subset of biomolecules from among the plurality of biomolecules from the one or more particle panels into the first solution; c) collecting the first subset of biomolecules from the first solution; d) contacting the one or more particles with a second solution, thereby desorbing a second subset of biomolecules from among the plurality of biomolecules from the one or more particles into the second solution; and e) collecting the second subset of biomolecules from the second solution.
However, in the analogous art of systems and methods for sample preparation, data generation, and protein corona analysis, Manning et al. teaches contacting the plurality of particles in the plurality of partitions from a particle panel with biomolecules of the complex biological sample to form biomolecule coronas, thereby generating the subset of biomolecules of the complex biological sample. For biomolecule corona analysis, it can comprise desorbing a plurality of proteins from the biomolecule corona into a desorbate solution. In some cases, a first portion of biomolecules from a biomolecule corona are desorbed from the biomolecule corona and discarded, and a second portion of biomolecules from a biomolecule corona are desorbed from the biomolecule corona and collected (e.g., for analysis) (see Manning et al., col. 1/lines 26-55, col. 27/lines 52-67). Two or more successive rounds of preparation from a single biomolecule corona (e.g., desorption and collection of a first subset of biomolecules from a biomolecule corona followed by desorption and collection of a second subset of biomolecules from a biomolecule corona) may generate two sets of biomolecules (see Manning et al., col. 28-29/lines 46-6).
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 contacting and collection of a plurality of biomolecules onto a particle panel to form a biomolecule corona on the particles of Siddiqui et al. to incorporate contacting the particles and biomolecule coronas with a desorbate solution to desorb either from the first or second biomolecule corona and collected (as taught by Manning et al.), for the benefit of providing ways of automating the generation of subsets of biomolecules from a complex biological sample (see Manning et al., col. 1/lines 26-55).
Regarding claim 13, Siddiqui et al. fails to teach wherein the first solution is different from the second solution.
However, Manning et al. teaches that two rounds for preparing analytes from a biomolecule corona for analysis may comprise desorbing different pluralities of proteins from a biomolecule corona. Two rounds may also comprise different desorption methods or conditions, such as different desorbate solution volumes, different desorbate solution types (e.g., desorbate solutions comprising different buffers or osmolarities), different temperatures, or different types and degrees of physical agitation (see Manning et al., col. 28-29/lines 46-6).
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 biomolecule fractionating method of Siddiqui et al. to incorporate the solutions in a first round being different from a second (as taught by Manning et al.), for the benefit of providing ways of automating the generation of subsets of biomolecules from a complex biological sample (see Manning et al., col. 1/lines 26-55).
Regarding claim 14, Siddiqui et al. fails to teach wherein the first solution comprises a higher concentration of an organic solvent than the second solution.
However, Manning et al. teaches that two rounds for preparing analytes from a biomolecule corona for analysis may comprise desorbing different pluralities of proteins from a biomolecule corona. Two rounds may also comprise different desorption methods or conditions, such as different desorbate solution volumes, different desorbate solution types (e.g., desorbate solutions comprising different buffers or osmolarities), different temperatures, or different types and degrees of physical agitation (see Manning et al., col. 28-29/lines 46-6).
While Siddiqui et al. doesn't explicitly teach the first solution comprising a higher concentration of an organic solvent than the second solution, it would have been obvious to one of ordinary skill to utilize the first solution comprising a higher concentration of an organic solvent than the second solution as it’s known in the art that altering the concentration of an organic solvent in a desorption solution (i.e., an organic solvent) alters the affinity of an adsorbate for a binding partner, and as a result of routine optimization (See MPEP 2144.05 regarding routine optimization; see also In reAller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) ("[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation"); see also Peterson, 315 F.3d at 1330, 65 USPQ2d at 1382 (Fed. Cir. 2003) ("The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set of percentage ranges is the optimum combination of percentages."). It also would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the biomolecule fractionating method of Siddiqui et al. to incorporate having the first solution comprise a higher concentration of organic solvent than the second solution (as taught by Manning et al.), for the benefit of providing ways of automating the generation of subsets of biomolecules from a complex biological sample (see Manning et al., col. 1/lines 26-55).
Regarding claim 15, Siddiqui et al. fails to teach wherein the first solution comprises a lower concentration of an organic solvent than the second solution.
However, Manning et al. teaches that two rounds for preparing analytes from a biomolecule corona for analysis may comprise desorbing different pluralities of proteins from a biomolecule corona. Two rounds may also comprise different desorption methods or conditions, such as different desorbate solution volumes, different desorbate solution types (e.g., desorbate solutions comprising different buffers or osmolarities), different temperatures, or different types and degrees of physical agitation (see Manning et al., col. 28-29/lines 46-6).
While Siddiqui et al. doesn't explicitly teach the first solution comprising a lower concentration of an organic solvent than the second solution, it would have been obvious to one of ordinary skill to utilize the first solution comprising a lower concentration of an organic solvent than the second solution as it’s known in the art that altering the concentration of an organic solvent in a desorption solution (i.e., an organic solvent) alters the affinity of an adsorbate for a binding partner, and as a result of routine optimization (See MPEP 2144.05 regarding routine optimization; see also In reAller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) ("[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation"); see also Peterson, 315 F.3d at 1330, 65 USPQ2d at 1382 (Fed. Cir. 2003) ("The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set of percentage ranges is the optimum combination of percentages."). It also would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the biomolecule fractionating method of Siddiqui et al. to incorporate having the first solution comprise a lower concentration of organic solvent than the second solution (as taught by Manning et al.), for the benefit of providing ways of automating the generation of subsets of biomolecules from a complex biological sample (see Manning et al., col. 1/lines 26-55).
Regarding claim 16, Siddiqui et al. fails to teach wherein the method comprises contacting the one or more particles with a third solution, thereby desorbing a third subset of biomolecules from among the plurality of biomolecules from the one or more particles into the third solution and collecting the third subset of biomolecules from the third solution.
However, Manning et al. teaches that the automated apparatus used in the method is configured to generate the subset of biomolecules by contacting the plurality of particles with the complex biological sample to form a plurality of biomolecule coronas comprising the subset of biomolecules. (see Manning et al., col. 7/lines 37-53). The method may comprise multiple rounds of preparing analytes from a biomolecule corona for analysis, consisting of 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, or more rounds of preparation. Each round produces a separate sample for analysis (e.g., desorbed biomolecules may be collected after each round and subjected to mass spectrometric analysis). Multiple rounds of preparation from a single biomolecule corona may be used to generate a number biomolecule subsets, as many as 960 unique biomolecule subsets when utilizing a substrate with 96 partitions (e.g., a 96 well plate) (see Manning et al., col. 28-29/lines 46-6).
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 biomolecule fractionating method of Siddiqui et al. to incorporate contacting the particles with a third solution (via a third round), thereby desorbing a third subset of biomolecule for collection (as taught by Manning et al.), for the benefit of providing ways of automating the generation of subsets of biomolecules from a complex biological sample (see Manning et al., col. 1/lines 26-55).
Regarding claim 17, Siddiqui et al. fails to teach wherein the first subset of biomolecules is different from the second subset of biomolecules and the third subset of biomolecules.
However, Manning et al. teaches that each round produces a separate sample for analysis, where two separate rounds can comprise desorbing different pluralities of proteins from a biomolecule corona, different desorption methods or conditions, such as different desorbate solution volumes, different desorbate solution types (e.g., desorbate solutions comprising different buffers or osmolarities), different temperatures, or different types and degrees of physical agitation. Two or more successive rounds of preparation from a single biomolecule corona (e.g., desorption and collection of a first subset of biomolecules from a biomolecule corona followed by desorption and collection of a second subset of biomolecules from a biomolecule corona) may generate two sets of biomolecules. (see Manning et al., col. 28-29/lines 46-6).
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 biomolecule fractionating method of Siddiqui et al. to incorporate the subsets in a first round being different from a second and third (as taught by Manning et al.), for the benefit of providing ways of automating the generation of subsets of biomolecules from a complex biological sample (see Manning et al., col. 1/lines 26-55).
Regarding claim 18, Siddiqui et al. fails to teach wherein contacting the one or more particles with a second solution is performed prior to contacting the one or more particles with a third solution and after contacting the one or more particles with a first solution.
However, Manning et al. teaches that the multiple rounds that may be performed are successive from preparation from a single biomolecule corona (e.g., desorption and collection of a first subset of biomolecules from a biomolecule corona followed by desorption and collection) from contact with the differing desorption methods and conditions of the desorbate solutions (see Manning et al., col. 28-29/lines 46-6).
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 biomolecule fractionating method of Siddiqui et al. to incorporate successive contact of particles with the numbered rounds of solutions (as taught by Manning et al.), for the benefit of providing ways of automating the generation of subsets of biomolecules from a complex biological sample (see Manning et al., col. 1/lines 26-55).
Regarding claim 19, Siddiqui et al. fails to teach wherein the third solution is different from the first or second solution.
However, Manning et al. teaches that two or more rounds for preparing analytes from a biomolecule corona for analysis may comprise desorbing different pluralities of proteins from a biomolecule corona. Two or more rounds may also comprise different desorption methods or conditions, such as different desorbate solution volumes, different desorbate solution types (e.g., desorbate solutions comprising different buffers or osmolarities), different temperatures, or different types and degrees of physical agitation (see Manning et al., col. 28-29/lines 46-6).
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 biomolecule fractionating method of Siddiqui et al. to incorporate the solutions in a third round being different from the first and second (as taught by Manning et al.), for the benefit of providing ways of automating the generation of subsets of biomolecules from a complex biological sample (see Manning et al., col. 1/lines 26-55).
Regarding claim 20, the combination of Siddiqui et al. and Manning et al. teaches the exact limitations of claim 20. Specifically, Siddiqui et al. teaches the method of claim 16, wherein the one or more particles comprise at least two particles, and the at least two particles comprise a particle panel (see Siddiqui et al., [00207], Fig. 5, disclosing particle panels comprising from 1 to 12 particles.).
Conclusion Any inquiry concerning this communication or earlier communications from the examiner should be directed to Tracy C Colena whose telephone number is (571)272-1625. The examiner can normally be reached Mon-Thus 8:00am-5:00pm.
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/TRACY CHING-TIAN COLENA/Examiner, Art Unit 1797
/JENNIFER WECKER/Primary Examiner, Art Unit 1797