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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 10/27/2025, has been entered.
Claim Objections
Claims 1, 64 are objected to because of the following informalities: need to add “of” between “inside” and “the” both in line 2 of the two claims. Appropriate correction is required.
Claim 65 is objected to because of the following informalities: need to add “the” before “increase in” in line 2. Appropriate correction is required.
Claim 66 is objected to because of the following informalities: need to add “the” before “increase in” in line 2; need to add “the” between “on” and “surface”. Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 6, 56 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding claim 6, Where applicant acts as his or her own lexicographer to specifically define a term of a claim contrary to its ordinary meaning, the written description must clearly redefine the claim term and set forth the uncommon definition so as to put one reasonably skilled in the art on notice that the applicant intended to so redefine that claim term. Process Control Corp. v. HydReclaim Corp., 190 F.3d 1350, 1357, 52 USPQ2d 1029, 1033 (Fed. Cir. 1999). The term “nanoparticle” in claim 6 is used by the claim to mean “particles in a size range of 1 nm-10 μm” while the accepted meaning is “nano-sized particle is the particle of matter 1 to 100 nanometres (nm) in diameter” The term is indefinite because the specification does not clearly redefine the term.
Regarding claim 56, the claim 56 recite the limitation " the collapsible non-hygroscopic net" in line 2, which was not cited in its dependent claim 1. There is insufficient antecedent basis for this limitation in the claim.
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.
Claims 1, 3, 4, 12, 13, 63, 65 are rejected under 35 U.S.C. 103) as being unpatentable over Luchini (US20090087346, herein Luchini), in the view of Liotta-1 (WO2018218254, herein Liotta-1, US20210132049 is used herein as machine translation).
Regarding claims 1, 3, 63, 65, Luchini teaches a nanoparticle [0083] comprising a core and a shell [0191], wherein the core comprises a molecular bait, [0191], and wherein the nanoparticle is configured to capture a biomolecule, a nucleic acid, an exosome, and/or a virus [0098] from solution [0094].
Luchini teaches the formation of the Poly(NIPAm-co-AA) Nanoparticles [0205], which is the polymers used to make the capture particles of the present invention, and including the N,N-cystaminebisacrylamide [0051] which is “made up of crosslinkable units” [0051], matches the “cleavable cross linker (N, N′-bis(acryloyl)cystamine, BAC)” [Instant App. P26; 0244]. Furthermore, Luchini teaches the particles can also be formed using reversible crosslinkers such as those formed from disulfide bonds that can be reversed by DTT [0067], wherein, the cystamine bisacrylamide (N,N′-Bis(acryloyl)cystamine, BAC) with disulfide bond that reduced by the reducing agents dithiothreitol (DTT), hence, collectively read on the cleavable crosslinker, which is known as chemical reagent used to bind molecules together with a bond designed to be reversed under specific, controlled conditions.
Luchini teaches the capture particles comprise fluorescent labels, enzyme [0063], which indicates the color emission, but does not disclose any specific enzyme to achieve the color change inside the nanoparticle are configured to produce an enzymatically amplified color reaction on interaction of the one or more antibodies with their respective target analytes captured by the nanoparticle.
However, Liotta-1 teaches immobilizing an enzyme within a hydrogel particle where “enzymatically amplified color reaction occurs inside the hydrogel particles containing the captured analyte” [0026] and the enzyme is horseradish peroxidase (HRP) [0046], bind HRP via the carbohydrate ligand in the hydrogel particles [0026], which collectively read on the enzymatically amplified color detection system and inside the nanoparticle, owing to the specific enzyme horseradish peroxidase (HRP), wherein, the bind HRP via the carbohydrate ligand is known as covalently bound enzyme to other molecules.
Luchini and Liotta-1 are considered analogous art because they are in the same field of endeavor, that of core-shell hydrogel based molecular baits for capturing nucleic acids, virus particles via enzyme selection toward color reaction upon the analytes are captured.
It would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have substitute the teachings of Liotta-1 and provide the feature of “enzymatically amplified color reaction occurs inside the hydrogel particles containing the captured analyte” [0026], and the enzyme is horseradish peroxidase (HRP) [0046], bind HRP via the carbohydrate ligand in the hydrogel particles [0026], into the molecular baits detection system design via introducing the color reaction which is from the specific enzyme taught by Liotta-1.
Doing so would further achieve the desired property of rapid color reaction and increasing visual detection sensitivity >1000 fold [0026], as taught by Liotta-1, which encompasses the claimed detection concentration of picogram per ml limitation.
Furthermore, the nanoparticle as taught by Luchini and Liotta-1 collectively set forth above, is capable of tune the hydrodynamic diameter of the nanoparticle, to allow one or more antibodies to access one or more target analytes captured by the nanoparticle, owing to the specificity of the Poly(NIPAm-co-AA) Nanoparticles [0205] including the N,N-cystaminebisacrylamide [0051]; “made up of crosslinkable units.” [0051] as taught by Luchini.
The “enzymatically amplified color reaction occurs inside the hydrogel particles containing the captured analyte” [0026] and the enzyme is horseradish peroxidase (HRP) [0046] as taught by Liotta-1, which is further capable of achieving an amount of the one or more antibodies bound to their respective target analytes inside the nanoparticle after increase in the hydrodynamic diameter to be least 40 times higher compared to the antibodies present on a surface of the nanoparticle before increase in the hydrodynamic diameter. This can further afford lead to the capability of the non-elution immune-based detection of the sample which is biological fluids, such as urine [0096], as the one or more target analytes, and further capable of detect the one or more target analytes having a concentration in picograms per ml of the solution.
Regarding claim 4, Luchini and Liotta-1 collectively teach the nanoparticle as set forth in claim 1 above. Luchini further teaches the sample as being biological fluids, such as urine [0096].
Luchini does not teach the specific process steps of sequestering the one or more target analytes from a whole volume of the fluid sample concentrating the one or more target analytes into a volume < 100 uL within the nanoparticle.
However, such limitations are product-by-process limitations. “[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process.” In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985) [See MPEP 2113]. In the present case, the product, nanoparticle with target analyte, appears to be the same as that produced by the product-by-process limitations.
Regarding claim 12, Luchini and Liotta-1 teach the nanoparticle of claim 1, as shown above. Luchini does not teach that wherein the one or more target analytes captured by the nanoparticle are configured to be displayed on a solid phase antibody for production of the enzymatically amplified color reaction inside the nanoparticle.
However, Liotta-1 teaches immobilizing an enzyme within a hydrogel particle where “enzymatically amplified color reaction occurs inside the hydrogel particles containing the captured analyte” [0026], which collectively read on the enzymatically amplified color detection system.
Luchini and Liotta-1 are considered analogous art because they are in the same field of endeavor, that of nanostructured hydrogel based functional absorbent for molecular bait application.
It would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to add the teachings of Liotta-1 and provide immobilizing an enzyme within a hydrogel particle where “enzymatically amplified color reaction occurs inside the hydrogel particles containing the captured analyte” [0026], into the molecular bait detection system design, as taught by Liotta-1. Doing so would further achieve the desired property of rapid color reaction and increasing visual detection sensitivity >1000 fold [0026], as taught by Liotta-1.
Regarding claim 13, Luchini teaches the sample as being urine [0096], but does not explicitly teach the where the nanoparticles have sensitivity of about 95% and specificity about 80% of the target analytes from a whole volume of the urine, the blood, and/or the saliva.
However, Liotta-1 teaches “the system of the present invention has achieved 96% sensitivity and 80% specificity” [0074] lie in the claimed ranges and in urine [0026].
Luchini and Liotta-1 are considered analogous art because they are in the same field of endeavor, that of nanostructured hydrogel based functional absorbent development.
It would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to add the teachings of Liotta-1 and provide wherein said “the system of the present invention has achieved 96% sensitivity and 80% specificity” [0074] into the nanoparticle detection system design. Doing so would further achieve the high-resolution detector product development.
Claims 5, 6, 7, 8, 53, 54, 55, 56, 58, 60 are rejected under 35 U.S.C. 103 as being unpatentable over Luchini (US20090087346, herein Luchini) and Liotta-1 (WO2018218254, herein Liotta-1, US20210132049 is used herein as machine translation) as applied in claim 1, in the view of Liotta (US20110236999, herein Liotta).
Regarding claim 5, Luchini and Liotta-1 collectively teach the nanoparticle as set forth in claim 1 above.
Luchini does not explicitly teach the wherein the core of the nanoparticle has surface area at least 1000 times greater than surface area of the shell of the nanoparticle.
However, Liotta teaches the host particle system (large) “particles in a size range of 1 nm-100 μm containing an internal affinity bait” [0082] and wherein the guest particle system (small) “capture particles flow within the immunoassay zones by wicking through different porosities, wherein the particles are in a size range from 1-1000 nanometers” [0083].
Luchini and Liotta are considered analogous art because they are in the same field of endeavor, that of PNIPAm copolymer based nanostructured hydrogel useful for target analyte retention.
It would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to add the teachings of Liotta and provide two particle systems and lead to the surface area ratio between each particle and lead to the ratio of wherein the core of the nanoparticle has surface area at least 1000 times greater than surface area of the shell of the nanoparticle, as taught by Liotta. Doing so would further achieve the desired property of trapped analyte within the particles is completely harvested from the starting sample solution concentrated in a much smaller volume and is protected from degradation, because it is bound to the affinity bait. The collected analyte, now stabilized in a small volume, can be stored or shipped. [0007], as taught by Liotta.
Regarding claim 6, Luchini, Liotta-1 and Liotta collectively teach the nanoparticle as set forth in claims 1 and 5 above Luchini teaches “the material is porous, lattice-like, honeycombed” [0102] reads on the particle open mesh structure; smart nanoparticles that can be pre-dispensed into a collection tube [0084] reads on non-aggregating, colloidal.
Luchini does not teach that >95% open void.
However, Liotta-1 teaches immobilizing an enzyme within a hydrogel particle where the internal high surface area of the hydrogel particles within an internal open volume that is 95 percent solute” [0026]. It is well know that in hydrogels, the open void content, which often referred to as the mesh size or porous structure, is directly proportional to the available volume for solute diffusion and encapsulation, which lies in the claimed range.
Luchini and Liotta-1 are considered analogous art because they are in the same field of endeavor, that of nanostructured hydrogel based functional absorbent development.
It would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to add the teachings of Liotta-1 and provide immobilizing an enzyme within a hydrogel particle where the internal high surface area of the hydrogel particles within an internal open volume that is 95 percent solute” [0026] into the detection system design. Doing so would further achieve the high detection sensitivity [0024], as taught by Liotta-1.
Regarding claims 7, 8, 54, 55, Luchini and Liotta-1 collectively teach the nanoparticle as set forth in claim 1 above.
Luchini does not teach the wherein the nanoparticles are immobilized on a collapsible non hygroscopic net such that the target analyte is preserved in a dry state and wherein a collection device comprising the collapsible non hygroscopic net is configured to collect a fluid sample such that the fluid sample is in dry state.
However, Liotta teaches “fluid containing the particles is allowed to passively wick into a permeable porous matrix, such as glass fiber” [0007], which reads on the collapsible non hygroscopic net, wherein the glass fiber is flexible and foldable which reads on the collapsible, further, the glass fiber cannot absorb the liquid, which reads on non hygroscopic net. Liotta further teaches particles do no migrate within the porous matrix [0007] which indicates the collapsible non hygroscopic net not imbibe the fluid sample, and “Samples were then dried with Speed Vac (ThermoFisher) and analyzed with ELISA or mass spectrometry.” [0068] which collectively read on the dry state of the analyte.
Luchini and Liotta are considered analogous art because they are in the same field of endeavor, that of PNIPAm based nanostructured hydrogel useful for target analyte retention.
It would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to add the teachings of Liotta and provide a collapsible non hygroscopic net for immobilization of the nanoparticles, as of fluid containing the particles is allowed to passively wick into a permeable porous matrix, such as glass fiber [0007]; particles do no migrate within the porous matrix [0007]; and Samples were then dried with Speed Vac (ThermoFisher) and analyzed with ELISA or mass spectrometry [0068].
Doing so would further achieve the desired property of trapped analyte within the particles is completely harvested from the starting sample solution concentrated in a much smaller volume and is protected from degradation, because it is bound to the affinity bait. The collected analyte, now stabilized in a small volume, can be stored or shipped [0007], as taught by Liotta.
Regarding claim 53, Luchini teaches the sample as being urine [0096].
Regarding claim 55, Luchini does not explicitly teach the glass wool.
However, Liotta teaches “porous glass, glass fibers” [0007], which collectively read on glass wool, also matches the “the affinity net is a glass wool or glass fiber net” [Instant App. Spec.P23, 00163].
Luchini and Liotta are considered analogous art because they are in the same field of endeavor, that of PNIPAm based nanostructured hydrogel useful for target analyte retention.
It would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have optimized Luchini to add the teachings of Liotta and provide “porous glass, glass fibers” [0007] into the detection system development, as taught by Liotta. Doing so would further achieve the desired property of trapped analyte within the particles is completely harvested from the starting sample solution concentrated in a much smaller volume and is protected from degradation, because it is bound to the affinity bait. The collected analyte, now stabilized in a small volume, can be stored or shipped. [0007], as taught by Liotta.
Regarding claim 56, Luchini and Liotta-1 collectively teach the nanoparticle as set forth in claim 1 above.
Luchini does not explicitly teach the wherein the nanoparticle is covalently attached to a collapsible non-hygroscopic net via a crosslinker.
However, Liotta teaches the hydrogel nanoparticles comprising: a) a molecular sieve portion; and b) an analyte binding portion; wherein the molecular sieve portion, analyte binding portion or both further comprise a crosslinked region. [0009], which indicates the particle binding the analyte from the molecular sieve portion via covalently bond with crosslinker.
Luchini and Liotta are considered analogous art because they are in the same field of endeavor, that of PNIPAm copolymer based nanostructured hydrogel useful for target analyte retention.
It would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to add the teachings of Liotta and provide the hydrogel nanoparticles comprising: a) a molecular sieve portion; and b) an analyte binding portion; wherein the molecular sieve portion, analyte binding portion or both further comprise a crosslinked region. [0009], as taught by Liotta. Doing so would further achieve the desired property of the nanoparticles are used to harvest, concentrate, and protect target analytes from degradation [0009], as taught by Liotta.
Regarding claim 58, Luchini teaches “The particles can also be formed using reversible crosslinkers” [0067] which can further bond to the “affinity baits” [0188] which reads on the non hygroscopic net, via the binding process of “covalently immobilized within the particles” [0188].
Regarding claim 60, Luchini does not explicitly teach tuberculosis.
However, Liotta-1 teaches a urinary direct antigen tests for Active Tuberculosis (TB) [0024].
Luchini and Liotta-1 are considered analogous art because they are in the same field of endeavor, that of the nanostructured hydrogel based functional absorbent for molecular bait application.
It would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to add the teachings of Liotta-1 and provide a urinary direct antigen tests for Active Tuberculosis (TB) [0024]. Doing so would further achieve the ability to detect tuberculosis from a sample.
Claims 64, 66-68 are rejected under 35 U.S.C. 103) as being unpatentable over Luchini (US20090087346, herein Luchini), in the view of Liotta-1 (WO2018218254, herein Liotta-1, US20210132049 is used herein as machine translation).
Regarding claims 64, 66, 68, Luchini teaches a nanoparticle [0083] comprising a core and a shell [0191], wherein the core comprises a molecular bait, [0191], and wherein the nanoparticle is configured to capture a biomolecule, a nucleic acid, an exosome, and/or a virus [0098] from solution [0094].
Luchini teaches “The polymers used to make the capture particles of the present invention; N,N-cystaminebisacrylamide [0051] which is “made up of crosslinkable units.” [0051], matches the “cleavable cross linker (N, N′-bis(acryloyl)cystamine, BAC)” [Instant App. P26; 0244]. Furthermore, Luchini teaches the particles can also be formed using reversible crosslinkers such as those formed from disulfide bonds that can be reversed by DTT [0067], wherein, the Cystamine bisacrylamide (N,N′-Bis(acryloyl)cystamine, BAC) with disulfide bond that reduced by the reducing agents dithiothreitol (DTT).
Collectively read on the cleavable crosslinker, which is a chemical reagent used to bind molecules together with a bond designed to be reversed under specific, controlled conditions.
Luchini teaches the capture particles comprise enzyme [0063], but does not teach that wherein the one or more enzymes inside the nanoparticle are configured to produce an enzymatically amplified color reaction on interaction of the one or more antibodies with their respective target analytes captured by the nanoparticle.
However, Liotta-1 teaches immobilizing an enzyme within a hydrogel particle where “enzymatically amplified color reaction occurs inside the hydrogel particles containing the captured analyte” [0026] and the enzyme is horseradish peroxidase (HRP) [0046], bind HRP via the carbohydrate ligand in the hydrogel particles [0026], which collectively read on the enzymatically amplified color detection system, owing to the specific enzyme horseradish peroxidase (HRP), further, the bind HRP via the carbohydrate ligand is known as covalently bound enzyme to other molecules.
Luchini and Liotta-1 are considered analogous art because they are in the same field of endeavor, that of core-shell hydrogel based molecular baits for capturing nucleic acids, virus particles via enzyme selection.
It would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have substitute the teachings of Liotta-1 and provide the feature of “enzymatically amplified color reaction occurs inside the hydrogel particles containing the captured analyte” [0026], and the enzyme is horseradish peroxidase (HRP) [0046], bind HRP via the carbohydrate ligand in the hydrogel particles [0026], into the molecular baits detection system design. Doing so would further achieve the desired property of rapid color reaction and increasing visual detection sensitivity >1000 fold [0026], as taught by Liotta-1.
Furthermore, the nanoparticle as taught by Luchini and Liotta-1 collectively set forth above, is capable of tune the hydrodynamic diameter of the nanoparticle, to allow one or more antibodies to access one or more target analytes captured by the nanoparticle, owing to the specificity of the N,N-cystaminebisacrylamide [0051]; “made up of crosslinkable units.” [0051] as taught by Luchini, and the “enzymatically amplified color reaction occurs inside the hydrogel particles containing the captured analyte” [0026] and the enzyme is horseradish peroxidase (HRP) [0046] as taught by Liotta-1.
Further this is capable of achieve wherein an amount of the one or more antibodies bound to their respective target analytes inside the nanoparticle after increase in the hydrodynamic diameter is at least 40 times higher compared to the antibodies present on a surface of the nanoparticle before increase in the hydrodynamic diameter.
This can further afford lead to the capability of the non-elution immune-based detection of the one or more target analytes and further capable of detect the one or more target analytes having a concentration in picograms per ml of the solution.
Regarding claim 67, Luchini and Liotta-1 collectively teach the nanoparticle as set forth in claim 64 above. Luchini teaches “the material is porous, lattice-like, honeycombed” [0102] reads on the particle open mesh structure. Smart nanoparticles that can be pre-dispensed into a collection tube [0084] reads on non-aggregating, colloidal.
Luchini does not teach that >95% open void.
However, Liotta-1 teaches immobilizing an enzyme within a hydrogel particle where the internal high surface area of the hydrogel particles within an internal open volume that is 95 percent solute” [0026], which lies in the claimed range.
Luchini and Liotta-1 are considered analogous art because they are in the same field of endeavor, that of nanostructured hydrogel based functional absorbent development.
It would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to add the teachings of Liotta-1 and provide immobilizing an enzyme within a hydrogel particle where the internal high surface area of the hydrogel particles within an internal open volume that is 95 percent solute” [0026] into the detection system design. Doing so would further achieve the high detection sensitivity [0024], as taught by Liotta-1.
Claim 69 is rejected under 35 U.S.C. 103 as being unpatentable over Luchini (US20090087346, herein Luchini) and Liotta-1 (WO2018218254, herein Liotta-1, US20210132049 is used herein as machine translation) as applied in claim 64, in the view of Liotta (US20110236999, herein Liotta).
Regarding claim 69, Luchini and Liotta-1 collectively teach the nanoparticle as set forth in claim 64 above.
Luchini does not explicitly teach the wherein the nanoparticle is covalently attached to a collapsible non-hygroscopic net via a crosslinker.
However, Liotta teaches the hydrogel nanoparticles comprising: a) a molecular sieve portion; and b) an analyte binding portion; wherein the molecular sieve portion, analyte binding portion or both further comprise a crosslinked region. [0009], which indicates the particle binding the analyte from the molecular sieve portion via covalently bond with crosslinker.
Luchini and Liotta are considered analogous art because they are in the same field of endeavor, that of PNIPAm copolymer based nanostructured hydrogel useful for target analyte retention.
It would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to add the teachings of Liotta and provide the hydrogel nanoparticles comprising: a) a molecular sieve portion; and b) an analyte binding portion; wherein the molecular sieve portion, analyte binding portion or both further comprise a crosslinked region. [0009], as taught by Liotta.
Doing so would further achieve the desired property of the nanoparticles are used to harvest, concentrate, and protect target analytes from degradation [0009], as taught by Liotta.
Response to Arguments
Applicant’s arguments, filed 10/27/2025, with respect to the rejection(s) of claim(s) 1 under 35 USC § 102(1) have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Luchini (US20090087346, herein Luchini), and Liotta-1 (WO2018218254, herein Liotta-1, US20210132049 is used herein as machine translation) as set forth in the new rejection above.
In response to applicant's argument that “Luchini's disclosure in paragraph [0051] takes the form of an open-ended laundry list”, is not persuasive.
In fact, Luchini teaches the formation of the Poly(NIPAm-co-AA) Nanoparticles [0205], which is the polymers used to make the capture particles of the present invention, and including the N,N-cystaminebisacrylamide [0051] which is “made up of crosslinkable units” [0051], matches the “cleavable cross linker (N, N′-bis(acryloyl)cystamine, BAC)” [Instant App. P26; 0244], and expressly identifies these as suitable materials for use in the same capacity as the materials included in the examples. It has been established that selection of a known material based on its suitability for its intended use is prima facie obvious. See MPEP 2144.07. See also In re Susi, 440 F.2d 442, 445 (CCPA 1971) (obviousness rejection affirmed where the genus of the prior art was “huge, but it undeniably include[d] at least some of the compounds recited in appellant's generic claims and [was] of a class of chemicals to be used for the same purpose as appellant's additives”).
In response to applicant's argument that “first and second references both teach away the non-elution immune-based detection of the molecule captured on the nanoparticle”, is not persuasive.
In fact, the nanoparticle as taught by Luchini and Liotta-1 collectively set forth above in the new rejection, is capable of tune the hydrodynamic diameter of the nanoparticle, to allow one or more antibodies to access one or more target analytes captured by the nanoparticle, owing to the specificity of the Poly(NIPAm-co-AA) Nanoparticles [0205] including the N,N-cystaminebisacrylamide [0051]; “made up of crosslinkable units.” [0051] as taught by Luchini, and the “enzymatically amplified color reaction occurs inside the hydrogel particles containing the captured analyte” [0026] and the enzyme is horseradish peroxidase (HRP) [0046] as taught by Liotta-1, which collectively further capable of achieve wherein an amount of the one or more antibodies bound to their respective target analytes inside the nanoparticle after increase in the hydrodynamic diameter is at least 40 times higher compared to the antibodies present on a surface of the nanoparticle before increase in the hydrodynamic diameter; which can further afford lead to the capability of the non-elution immune-based detection of the sample which is biological fluids, such as urine [0096], as the one or more target analytes, and further capable of detect the one or more target analytes having a concentration in picograms per ml of the solution. Hence, neither Luchini nor Liotta-1 teaches away the instant application.
The declaration under 37 CFR 1.132 filed in 10/27/2025 is insufficient to overcome the rejection as set forth above because:
First, the nanoparticle as taught by Luchini and Liotta-1 collectively set forth above in the new rejection, is capable of tune the hydrodynamic diameter of the nanoparticle, to allow one or more antibodies to access one or more target analytes captured by the nanoparticle, owing to the specificity of the Poly(NIPAm-co-AA) Nanoparticles [0205] including the N,N-cystaminebisacrylamide [0051]; “made up of crosslinkable units.” [0051] as taught by Luchini, and the “enzymatically amplified color reaction occurs inside the hydrogel particles containing the captured analyte” [0026] and the enzyme is horseradish peroxidase (HRP) [0046] as taught by Liotta-1, which collectively further capable of achieve wherein an amount of the one or more antibodies bound to their respective target analytes inside the nanoparticle after increase in the hydrodynamic diameter is at least 40 times higher compared to the antibodies present on a surface of the nanoparticle before increase in the hydrodynamic diameter; which can further afford lead to the capability of the non-elution immune-based detection of the sample which is biological fluids, such as urine [0096], as the one or more target analytes, and further capable of detect the one or more target analytes having a concentration in picograms per ml of the solution. Hence, neither Luchini nor Liotta-1 teaches away the instant application.
Second, Luchini explicitly teaches the formation of the Poly(NIPAm-co-AA) Nanoparticles [0205], which is the polymers used to make the capture particles of the present invention, and including the N,N-cystaminebisacrylamide [0051] which is “made up of crosslinkable units” [0051], matches the “cleavable cross linker (N, N′-bis(acryloyl)cystamine, BAC)” [Instant App. P26; 0244], and expressly identifies these as suitable materials for use in the same capacity as the materials included in the examples. It has been established that selection of a known material based on its suitability for its intended use is prima facie obvious. See MPEP 2144.07. See also In re Susi, 440 F.2d 442, 445 (CCPA 1971) (obviousness rejection affirmed where the genus of the prior art was “huge, but it undeniably include[d] at least some of the compounds recited in appellant's generic claims and [was] of a class of chemicals to be used for the same purpose as appellant's additives”).
Third, Luchini, Liotta-1 and Liotta collectively teach the nanoparticle as set forth in the rejection above. Applicants fail to provide an argument that the non-elution property would not an unexpected result, via the selection of the crosslinker which explicitly taught by Luchini, namely, the N,N-cystaminebisacrylamide [0051] which is “made up of crosslinkable units” [0051], matches the “cleavable cross linker (N, N′-bis(acryloyl)cystamine, BAC)” [Instant App. P26; 0244]; and Luchini further explicitly teaches the particles can also be formed using reversible crosslinkers such as those formed from disulfide bonds that can be reversed by DTT [0067], wherein, the cystamine bisacrylamide (N,N′-Bis(acryloyl)cystamine, BAC) with disulfide bond that reduced by the reducing agents dithiothreitol (DTT), hence, collectively read on the cleavable crosslinker, which is known as chemical reagent used to bind molecules together with a bond designed to be reversed under specific, controlled conditions. Hence, Luchini not only does not teach away the instant application, but also collectively teach the nanoparticle with the prior arts Liotta-1 and Liotta, which lead to the further achieve the high detection sensitivity [0024], as taught by Liotta-1, further meets the hydrogel nanocage affinity bait harvesting technology, and used the technology to successfully detect very low abundance (picogram/mL) pathogen shed antigens in urine or other body fluids with high sensitivity and specificity [Instant App. US20240142444; 0138], and achieve the desired property of the nanoparticles are used to harvest, concentrate, and protect target analytes from degradation [0009], as taught by Liotta, further meet the nanoparticle harvested analytes are preserved against degradation [Instant App. US20240142444; 0168].
Correspondence
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/Z. L./Examiner, Art Unit 1767
/KATARZYNA I KOLB/Primary Examiner, Art Unit 1767 February 27, 2026