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 39-58 are pending. Claims 55-58 are withdrawn. Claims 39-54 are under examination.
Election/Restrictions
Applicant’s election without traverse of Group I (claims 39-54) in the reply filed on 08/06/2026 is acknowledged.
Claims 55-58 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected group there being no allowable generic or linking claim. Election was made without traverse.
Claim Objections
Claims 46 and 50 are objected to because of the following informalities: These claims appear to invoke the Markush language which should be recited as – selected from the group consisting of….. and…–. If Applicant did not intend to invoke the Markush language for these claims, please make the changes to recite a different alternative form. 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 39-54 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.
Claim 39 recites the limitation of an antibody conjugated to a surface of the quantum dot-polymer composite and specifically binding to a target specimen is unclear whether the structure of the immunodetection conjugate has a target specimen bound to the antibody or the recitation is intended use. Because the claim is reciting a structure describing the immunodetection conjugate, it is unclear to the overall structure of the recited conjugate. Claims 40-54 are rejected as being dependent from claim 39.
Claim 48, the claim is unclear to the structure of the limitations of the hydrophobic portion is aligned toward the center direction of the quantum-bead and the hydrophilic portion is aligned toward the outside direction of the quantum bead. The structures of these phrases “center direction” and “outside direction” are unclear to the orientations and alignments for these portions.
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 39-49 are rejected under 35 U.S.C. 103 as being unpatentable over Schneck et al. (US20160051698, published 02/25/2016) in view of Guo et al. (US2014/0001405A1, published 01/02/2014).
With respect to claims 39-40 and 42, Schneck teaches an artificial antigen presenting cells (aAPC), which deliver stimulatory signals to lymphocytes, including cytotoxic lymphocytes (at abstract). Schneck teaches in Fig. 5A a quantum dot core coated with polymer with conjugated IgG antibody, which would read on an immunodetection conjugate, comprising a quantum dot-polymer composite and an antibody conjugated to a surface of the quantum dot-polymer composite and specifically binding to a target specimen, wherein the quantum dot-polymer composite comprises a quantum-bead of a 3D self- assembly structure which comprises one quantum dot that has a core-shell structure, a surface-modifying ligand arranged on the surface of the quantum dot (e.g., polymer coating) and one or more polymer ligands (e.g., avidin). Schneck teaches a zinc selenide (ZnSe) shell for the quantum dots (at bottom of para. [0131]). Schneck teaches quantum dots include indium-phosphide (InP) (at para. [0128]). Schneck teaches quantum dot can range from 2 to 20 nm (at para. [0128]). Schneck teaches quantum dots can be engineered to be sensitive to energy in the infrared region, the visible spectrum, and even ultraviolet range through changes in size and composition and they can be designed to be either photoluminescent or photovoltaic, producing either light or energy (at para. [0126]). Schneck teaches the thickness of such coatings can be controlled to provide adequate stability (at para. [0094]).
Even though Schneck teaches a ZnSe shell as part of quantum dots, the reference does not teach a thickness of 3 nm to 9 nm (claims 39-40) or exemplify that the shell comprises 2 or more different types of inorganic particles (claim 42).
Guo teaches highly luminescent nanostructures, particularly highly luminescent quantum dots and enriching the nanostructure cores with indium and techniques for shell synthesis (at abstract). Guo teaches the production of core/shell quantum dots where the shell comprises at least two layers and the first layer comprises ZnSSe and the second layer comprises ZnS (at para. [0021]). Guo teaches the thickness of the shell layers can be conveniently controlled by controlling the amount of precursor provided (at para. [0024]). Guo also teaches suitable precursor amounts for various resulting desired shell thickness can be readily calculated (at para. [0128]). Guo teaches InP/ZnSSe/ZnS core-shell quantum dots (at para. [0028]). Guo teaches the highly luminescent nanostructures includes shells wherein the shell can increase the quantum yield and/or stability of the nanostructures (at para. [0101]). Guo teaches providing a thin intermediate layer of ZnSSe over the InP core increases quantum yield and ZnS outer layer further increases quantum yield and also enhances stability of the nanostructures (at para. [0123]).
Therefore, 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 produced the quantum dots as taught by Schneck with a desirable thickness as taught by Guo because Schneck recognizes thickness of coatings can be controlled to provide adequate stability and Guo teaches the shell thickness can be calculated for desired results and shells are included to increase quantum yield and provide stability to the nanostructure cores.
Also, 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 for a result effective variable in producing core/shell quantum dots for desirable luminescent nanoparticle. “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum of workable ranges by routine experimentation” Application of Aller, 220 F.2d 454, 456, 105 USPQ 233, 235-236 (C.C.P.A. 1955). “No invention is involved in discovering optimum ranges of a process by routine experimentation.” Id. at 458, 105 USPQ at 236-237. The “discovery of an optimum value of a result effective variable in a known process is ordinarily within the skill of the art.” Since applicant has not disclosed that the thickness of the shell as recited in the claims is for any particular purpose or solve any stated problem. Absence of unexpected results, it would have been obvious for the person of ordinary skill to discover the optimum effective precursor concentration to produce the shell to maintain stability for different core size particles.
Furthermore, it would have been motivated to have added an intermediate shell into the quantum dots of Schneck because it would be desirable to have added a thin intermediate layer of ZnSSe over the InP core to increase quantum yield and ZnS outer layer to further increase quantum yield and enhance stability for the quantum dots, as taught by Guo.
The person would have a reasonable expectation of success incorporating shells that comprise at least two different inorganic particles because it has been well understood by Schneck and Guo to produce core/shell quantum dots.
With respect to claim 41, Schneck teaches a zinc selenide (ZnSe) shell for the quantum dots (at bottom of para. [0131]).
With respect to claim 42, see above.
With respect to claim 43, as stated above, Schneck does not teach the shell comprises a first shell layer and a second shell layer. However, it would have been obvious to a person to have produced the quantum dots as taught by Schneck with a desired thickness as taught by Guo because Schneck recognizes thickness of coatings can be controlled to provide adequate stability and Guo teaches the shell thickness can be calculated for desired results and shells are included to increase quantum yield and provide stability to the nanostructure cores.
Additionally, it would have been motivated to have added an intermediate shell into the quantum dots of Schneck because it would be desirable to have added a thin intermediate layer of ZnSSe over the InP core to increase quantum yield and ZnS outer layer to further increase quantum yield and enhance stability for the quantum dots, as taught by Guo.
With respect to claim 44, as stated above, Schneck does not teach the shell comprises a first shell layer and a second shell layer. Because Scheck and Guo teach the same structure of shell layers (InP/ZnSSe/ZnS) it would be obvious that the band gap of the second inorganic particle is greater than the band gap of the first inorganic particle.
With respect to claim 45, Schneck teaches molecules can be directly attached to nanoparticles by direct chemical bonding wherein the activating functional groups include sulfhydryls (i.e., thiol) (at para. [0097]).
With respect to claim 46, Schneck teaches a nanoparticle is coated before proteins wherein coated with random copolymers (at para. [0090]).
With respect to claim 47, Schneck teaches the copolymer is used that includes a lysine and alanine (at bottom of para. [0090]), which would contain a polymer ligand each comprises a hydrophobic portion and a hydrophilic portion.
With respect to claim 48, Schneck teaches the copolymer is used that includes a lysine and alanine (at bottom of para. [0090]), which would read on the claimed structure of the polymer ligand. Therefore, the hydrophobic portion of the polymer ligand would be aligned toward a center direction of the quantum-bead, and the hydrophilic portion of the polymer ligand would be aligned toward the outside direction of the quantum-bead.
With respect to claim 49 Schneck teaches the copolymer is used that includes a lysine (at bottom of para. [0090]).
Claims 39-41 and 45-51 are rejected under 35 U.S.C. 103 as being unpatentable over Schneck et al. (US20160051698, published 02/25/2016) in view of Hammond et al. (US2014/0093575A1, published 04/03/2014).
Schneck has been discussed above but the reference does not teach a thickness of 3 nm to 9 nm (claims 39-40), and the one polymer ligand comprises polycarbonates, polyester or polyacrylic acid (claim 50).
Hammond teaches systems for coating a particle core with a layer-by-layer film (see abstract). Hammon teaches each layer is ~ 2 nm thick (at paras. [0020] and [0025]). Hammon teaches PLL and DXS layers are ~ 3 nm and 5 nm thick respectively (at para. [0037]). Hammond teaches the additional of the trilayer architecture (PLLib/nav/PEG) increased the hydrodynamic diameter of the original particles from ~20 nm to ~ 80 nm, with most of the increase attributed to the terminal PEG layer (at para. [0173]). Fig. 19A teaches different diameters with different layers. Hammond teaches a carboxyl functionalized quantum dot was used to build the LbL nanoparticles (at paras. [0021], [0025] and [0073]; and Fig. 7A). Hammond teaches polyester (at para. [0078]). Hammond teaches the outer layer comprising carboxymethyldextran, polyacrylic acid, or copolymer thereof (at para. [0094]).
Therefore, 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 produced the quantum dots as taught by Schneck with a desirable thickness as taught by Hammond because Schneck recognizes thickness of coatings can be controlled to provide adequate stability and Hammon teaches different polymer layers and thicknesses are applied onto quantum dots.
Furthermore, 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 for a result effective variable in producing core/shell quantum dots for desirable luminescent nanoparticle. “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum of workable ranges by routine experimentation” Application of Aller, 220 F.2d 454, 456, 105 USPQ 233, 235-236 (C.C.P.A. 1955). “No invention is involved in discovering optimum ranges of a process by routine experimentation.” Id. at 458, 105 USPQ at 236-237. The “discovery of an optimum value of a result effective variable in a known process is ordinarily within the skill of the art.” Since applicant has not disclosed that the thickness of the shell as recited in the claims is for any particular purpose or solve any stated problem. Absence of unexpected results, it would have been obvious for the person of ordinary skill to discover the optimum effective precursor concentration to produce the shell to maintain stability for different core size particles.
Additionally, it would have been obvious to the person to have produced the quantum dots as taught by Schneck with the polymers as taught by Hammond because Schneck teaches polymer coating such as dextran onto nanoparticles and Hammond recognizes using carboxymethyldextran and/or polyacrylic acid as the outer layer of the quantum dots.
The person would have a reasonable expectation of success incorporating the polymer ligands because it has been well understood in the art to coat polymers on quantum dots.
With respect to claim 51, Schneck teaches the nanoparticle size may be 75-100 nm (at para. [0116]). Schneck does not teach quantum-bead has a hydrodynamic diameter of 50 nm to 1000 nm. Hammond teaches the additional of the trilayer architecture (PLLib/nav/PEG) increased the hydrodynamic diameter of the original particles from ~20 nm to ~ 80 nm, with most of the increase attributed to the terminal PEG layer (at para. [0173]). Therefore, it would have been obvious to have increased the hydrodynamic diameter through the addition of polymer layers.
Claims 39-41, 45-49 and 52-54 are rejected under 35 U.S.C. 103 as being unpatentable over Schneck et al. (US20160051698, published 02/25/2016) in view of Deng et al. (US2016/0238591A1, published 08/18/2016).
Schneck has been discussed in the above rejection. Schneck teaches biotinylated molecules (at bottom of para. [0097]), but the reference does not teach a thickness of 3 nm to 9 nm (claims 39-40) and an isopeptide bond between a first peptide tag and a second peptide tag (claim 52) wherein the first and second peptides are spytag and spycatcher (claim 53).
Deng teaches compositions that include at least one nanoparticle linked to a first polypeptide and a biological synthesizable polymer linked to at least one second polypeptide that binds covalently to the first polypeptide (abstract). Deng teaches a biopolymer linked to at least two polypeptides, each polypeptide covalently linked through an isopeptide bond to a nanoparticle-polypeptide conjugate (para. [0016]). Deng teaches quantum dot (QD)-SpyCatcher conjugates and specific to spy-tag (at para. [0068]). Deng teaches the methods and compositions for synthesizing programmable self-assembling scaffolds for use with a variety of nanotechnology and/or biological applications and these methods for achieving rapid and robust nanoparticle-protein conjugation (at para. [0091]). Deng further teaches robust nanoparticle-protein conjugates that are highly stable and fluorescent, and can be used with a wide range of, for example, semiconductor materials with variable compositions (at para. [0091]). Deng also teaches the semiconductor materials include indium phosphide (at para. [0098]). Deng also teaches the polypeptide that is linked to the nanoparticle through a peptide linker (at para. [0114]). Deng teaches high starting thickness of the CdS shell (at para. [0170).
Therefore, 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 produced the quantum dots with a desirable thickness as taught by Schneck because Schneck recognizes thickness of coatings can be controlled to provide adequate stability. Meanwhile, 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 for a result effective variable in producing core/shell quantum dots for desirable luminescent nanoparticle. “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum of workable ranges by routine experimentation” Application of Aller, 220 F.2d 454, 456, 105 USPQ 233, 235-236 (C.C.P.A. 1955). “No invention is involved in discovering optimum ranges of a process by routine experimentation.” Id. at 458, 105 USPQ at 236-237. The “discovery of an optimum value of a result effective variable in a known process is ordinarily within the skill of the art.” Since applicant has not disclosed that the thickness of the shell as recited in the claims is for any particular purpose or solve any stated problem. Absence of unexpected results, it would have been obvious for the person of ordinary skill to discover the optimum effective precursor concentration to produce the shell to maintain stability for different core size particles.
Additionally, it would have been obvious to the person to have used the quantum dots as taught by Schneck with the pair of spycatcher and spytag as taught by Deng because Schneck teaches using avidin-biotin pair chemistry for conjugation and Deng teaches that spycatcher-spytag is a self-assembled chemistry that achieves rapid quantum dot conjugation and the robust nanoparticle-protein conjugates are highly stable with semiconductor materials such as indium phosphide. Thus, the person would have a reasonable expectation of success in replacing avidin-biotin pair with spycatcher-spytag pair because it has been well understood by Schneck and Deng to use high affinity binding partners for core-shell quantum dots that include indium phosphide.
With respect to claim 54, as stated above, Schneck does not teach a first peptide tag and a second peptide tag. Deng teaches use peptide linkages such as cysteine (Cys) linkages (at para. [0091]). Thus, it would have been obvious to have used the spycatcher-spytag to conjugate at quantum dots and antibodies at the Fc region because Schneck teaches the Fc region of the antibody is conjugated to the quantum dot (at Fig. 5A) and the other regions are for specific binding.
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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