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 .
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.
Status of Claims
Claims 1-14 are pending and under examination.
Claim Objections
Claim 12 is objected to because of the following informalities: Claim 12 appears to invoke a Markush language but the language requires “selected from the group consisting of”. Appropriate correction is required.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-2 and 11-13 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Lin et al. (“Diagnosis by simplicity: an aptachip for dopamine capture and accurate detection with a dual
colorimetric and fluorometric system”, Journal of Materials Chemistry B, vol. 6, pgs. 3387-3394, published 05/04/2018).
Lin teaches an aptachip with a dual colorimetric and fluorometric sensing strategy for easy dopamine DA detection with high sensitivity and selectivity (at abstract). Lin further teaches to construct an aptachip with high DA capture efficiency, molecular dynamics (MD) simulations were utilized to predict the most stable configuration of the DA-binding aptamer (DBA) for DA recognition (at abstract). Lin teaches surface cleaning of chips and the washed chips were stored in ethanol (99%) for future use designated as chip pre-washed (at pg. 3388, right col., para. 3). Lin teaches one bPEI chain with 10 monomers on SiO2 substrate surface was considered and Figs. 2A and B show the bPEI model and the SiO2 substrate model (at pg. 3390, right col., para. 1 and pg. 3388, right col., para. 4). Fig. 2C further teaches bPEI adsorbed on the pre-washed chip (also at caption). Figs. 2A and C show the active polymer layer has a coupling surface and an active surface opposite of the coupling surface and wherein the active polymer layer couples to the silicon-containing substrate (i.e., SiO2 substrate) by the coupling surface. Fig. 1 teaches coupling the plurality of capture biomolecules (i.e., dopamine-binding aptamer) to the active surface of the active polymer (i.e., bPEI).
With respect to claim 2, Lin teaches surface cleaning of chips and the washed chips were stored in ethanol (99%) for future use designated as chip pre-washed (at pg. 3388, right col., para. 3). Fig. 1 shows the fabrication through the negative charges for bPEI.
With respect to claims 11-13, Lin teaches branched polyethylenimine (bPEI) (at pg. 3388, left col., para. 1 of Experimental section).
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 1-4, 6-9 and 11-14 are rejected under 35 U.S.C. 103 as being unpatentable over Lin et al. (“Diagnosis by simplicity: an aptachip for dopamine capture and accurate detection with a dual colorimetric and fluorometric system”, Journal of Materials Chemistry B, vol. 6, pgs. 3387-3394, published 05/04/2018) in view of McGonigle et al. (WO2009/126830A2, published 10/15/2009, IDS submitted on 06/20/2024, cite no. 2) and Hurst et al. (“Maximizing DNA Loading on a Range of Gold Nanoparticle Sizes”, Anal Chem. Vol. 78(24), 8313-8318, pgs. 1-13, published 12/15/2006).
With respect to claims 1, 3 and 6, Lin teaches an aptachip with a dual colorimetric and fluorometric sensing strategy for easy dopamine DA detection with high sensitivity and selectivity (at abstract). Lin further teaches to construct an aptachip with high DA capture efficiency, molecular dynamics (MD) simulations were utilized to predict the most stable configuration of the DA-binding aptamer (DBA) for DA recognition (at abstract). Lin teaches surface cleaning of chips and the washed chips were stored in ethanol (99%) for future use designated as chip pre-washed (at pg. 3388, right col., para. 3). Lin teaches one bPEI chain with 10 monomers on SiO2 substrate surface was considered and Figs. 2A and B show the bPEI model and the SiO2 substrate model (at pg. 3390, right col., para. 1 and pg. 3388, right col., para. 4). Fig. 2C further teaches bPEI adsorbed on the pre-washed chip (also at caption). Figs. 2A and C show the active polymer layer has a coupling surface and an active surface opposite of the coupling surface and wherein the active polymer layer couples to the silicon-containing substrate (i.e., SiO2 substrate) by the coupling surface. Fig. 1 teaches coupling the plurality of capture biomolecules (i.e., dopamine-binding aptamer) to the active surface of the active polymer (i.e., bPEI). Lin teaches that the aptamers are synthetic single-stranded DNA or RNA molecules that are similar to antibodies because of excellent recognition of (and binding to) target molecules (at pg. 3388, bottom of para. 1).
Although Lin teaches employing a negative charge surface to apply branched polyethylenimine polymer through charge interactions and incorporating aptamer, the reference fails to teach the capture biomolecules have negative charges and electrostatically bonded to the polymer layer (claim 3) and noble metal nanoparticles (claim 6).
McGonigle teaches embodiments of devices for the controlled elution of nucleic acid delivery complexes wherein the device includes a substrate surface, a polymeric coating disposed on the surface, the polymeric coating coupled to the substrate surface and the polymeric coating comprising negatively charged species on the surface and a plurality of nucleic acid delivery complexes disposed on the polymeric coating, the nucleic acid delivery complexes comprising a nucleic acid and cationic carrier agent complexed to the nucleic acid (at abstract and Fig. 1). McGonigle teaches polyethylenimine (PEI) and poly(beta-aminoesters) (at pg. 8, lines 3-9). McGonigle further teaches the substrate is silicon (see pg. 22, lines 4-5). McGonigle teaches nucleic acids include RNA or DNA (at pg. 8, lines 15-19). McGonigle teaches the surface includes negatively charged groups that are electrostatically bonding to nucleic acid delivery complexes (see pg. 6, lines 5-6). McGonigle further teaches the carriers conjugated to molecules which allow them to target specific cell types and such targeting agents include antibodies and peptides which recognize and bind to specific cell surface molecules (see pg. 8, lines 10-14). McGonigle further teaches the substrate is silicon (see pg. 22, lines 4-5). McGonigle teaches a polymer solution onto a substrate to form a coated substrate and the polymer solution comprising a polymer with negatively charged species (at pg. 33, lines 15-20).
Hurst teaches investigated DNA coverage on gold nanoparticles and stable large particles are attractive for a variety of biodiagnostic assays (at abstract). Hurst teaches gold nanoparticles exhibit several interesting physical and chemical properties and gold nanoparticles are important because they can be stabilized with a wide variety of molecules by taking advantage of well known chemistry involving alkyl thiol adsorption on gold (at pg. 1, para. 1). Hurst teaches that since the development of the colorimetric assays, DNA functionalized Au nanoparticles have become a central component in a wide variety of schemes (at pg. 1, para. 2 of introduction). Hurst teaches electrostatic interactions between the positively charged Tris molecules and the negatively charge DNA backbone (at pg. 4, para. 2). Hurst teaches that the tendency of the DNA bases to interact with the gold will cause the DNA to partially lie on the gold surface (at pg. 5, para. 1).
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to have employed the aptachip as taught by Lin with particles containing charges as taught by McGonigle and Hurst for simple diagnostic because Lin, McGonigle and Hurst all recognize employing opposite charges for attraction. Thus, it would have been obvious to have employed gold nanoparticles coated with DNA (negative charges) onto the aptachip because DNA will attract to the positive charges of the polymer on the surface of the aptachip and provide biodetection. Because Lin teaches using single stranded DNA to capture targets, it would have been obvious to have used gold nanoparticles coated with DNA for target binding and colorimetric detection based on target binding.
The person would have a reasonable expectation of success employing DNA (negative charge) onto the aptachip because it has been well understood by the references that opposite charge attracts and Lin teaches ssDNA and gold nanoparticles are used.
With respect to claim 4, Lin teaches in Fig. 1 the plurality of capture biomolecules couples to a covered area of the active surface of the at least one active polymer layer, and wherein the active surface of the at least one active polymer layer further comprises an exposed area to which the plurality of capture biomolecules does not couple.
With respect to claim 6, see above rejection.
With respect to claim 7, as stated above, Lin does not teach noble nanoparticles. Hurst teaches DNA coated gold nanoparticles. Thus, it would have been obvious to have employed gold nanoparticles coated with DNA (negative charges) onto the aptachip because DNA will attract to the positive charges of the polymer on the surface of the aptachip and provide biodetection. Because Lin teaches using single stranded DNA to capture targets, it would have been obvious to have used gold nanoparticles coated with DNA for target binding and colorimetric detection based on target binding.
With respect to claim 8, Hurst teaches DNA based PEG spacers with thiol functionality (see pg. 2, para. 3). Because Hurst teaches the claimed structures of the capture biomolecule and noble metal nanoparticles, the bond would be covalent.
With respect to claim 9, as stated above, Lin does not teach noble metal nanoparticles coupled to the biosensor. However, Lin does teach in Fig. 1 the plurality of capture biomolecules couples to a covered area of the active surface of the at least one active polymer layer, and wherein the active surface of the at least one active polymer layer further comprises an exposed area to which the plurality of capture biomolecules does not couple. Therefore, it would have been obvious to area that the nanoparticles are covered are dependent on the amount employed on the surface of the sensor.
With respect to claims 11-13, Lin teaches branched polyethyleneimine (bPEI) (at pg. 3388, left col., para. 1 of Experimental section).
With respect to claim 14, Lin does not teach poly(beta aminoester). McGonigle teaches polyethylenimine (PEI) and poly(beta-aminoesters) (at pg. 8, lines 3-9). McGonigle further teaches the substrate is silicon (see pg. 22, lines 4-5). Therefore, it would have been obvious to have used poly(beta aminoester) because McGonigle recognizes the use of polyethylenimine (PEI) and poly(beta-aminoesters) for positive charges.
Claims 5 and 10 are rejected under 35 U.S.C. 103 as being unpatentable over Lin et al. in view of McGonigle et al. and Hurst et al., as applied to claim 4 or 9 above, and further in view of Brosel-Oliu et al. (“Impedimetric label-free sensor for specific bacteria endotoxin detection by surface charge registration”, Electrochimica Acta 243 (2017) 142–151).
Brosel-Oliu teaches impedimetric sensor and the surface was carried out using layer-by-layer method with polyethyleneimine (PEI) polycation and to prevent non-specific adsorption on PEI covered surface different blocking strategies were tested to achieve the specific response and blocking with BSA (see abstract). Brosel-Oliu teaches protein-based blocking reagents especially BSA are widely used in different applications and here BSA was employed due to its ability to interact with PEI (at pg. 147, left col., para. 1 of section 3.3.1). Brosel-Oliu teaches PEI which bears positive charge adsorbs strongly on silicon dioxide surface due to the presence of hydroxyl groups and increases the surface conductivity (at pg. 146, right col., para. 1 of section 3.2).
Thus, it would have been obvious to the person to have employed BSA as the blocking reagent for the aptachip of Lin because BSA is well recognized in the art as a blocking reagent and Brosel-Oliu recognizes using BSA for polyethyleneimine polymer.
Conclusion
No claim is allowed.
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/N.P.N/Examiner, Art Unit 1678
/SHAFIQUL HAQ/Primary Examiner, Art Unit 1678
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