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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 12/29/2025 has been entered.
Status of the Claims
Claim 2 is cancelled by Applicant’s amendment. Claim 3 is pending and examined herein.
Information Disclosure Statement
The Information Disclosure Statement filed 12/29/2025 is acknowledged and has been considered.
Priority
This application, filed on 06/30/2022, is a 371 of PCT/CN2020/126382, filed on 11/04/2020, which claims benefit to foreign application CHINA 202010063962.7, filed on 01/20/2020. This priority is acknowledged and the claims herein are considered to have an effective filing date of 01/20/2020.
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.
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.
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over CN102161716A “Method and reagent for latex sensitization” (published 08/24/2011, herein referred to as Aimin) in view of US Patent 5,739,290 “Monoclonal antibody against an interferon-induced human protein in pure form” (published 04/14/1998, herein referred to as Horisberger) as evidenced by https://www.ncbi.nlm.nih.gov/nuccore/NG_027788.2 and Molina-Bolivar et al., “Latex Immunoagglutination Assays” (published 12/01/2011, referred to herein as Bolivar) and further in view of “Latex Bead Technical Overview” (ThermoFisher Scientific, captured via Wayback Machine from 12/11/2019, referred to herein as Thermo).
Aimin’s general disclosure relates to a kit for use in a latex immunoturbidity assay (p. 1, lines 16-18) and describes specific components and concentrations for use in the latex immunoturbidity assay in the kit, as described below.
Regarding claim 3, Aimin discloses a kit containing reagents for use in latex immunoturbidimetric assays (p. 2, lines 30). Aimin discloses the reagents for use in the assay as a first reagent (p. 5, line 31. “R1”) and a second reagent (p. 5, line 41. “R2”). Aimin discloses that the reagents are buffers and that “reagents R1 and R2 may further contain surfactants, preservatives, polymers, etc. as needed” (p. 4, line 27). Aimin discloses R1 components with ranges of: 10-600mM NaCl concentration (p. 2, line 56) which includes the claimed 0.9% NaCl (154mM), 0.01-5% PEG-6000 (p. 2, lines 58-59), 0.01-2% BSA (p. 3, line 6), 0.01-0.1% sodium azide (p. 2, line 59 – p. 3, line 1), and 10-500mM Tris-HCl (p. 2, line 44). Aimin discloses R2 components with ranges of: 0.01-1% coated latex particles (p. 3, line 5), 10-500mM glycine (p. 3, line 4), 10-600mM NaCl concentration (p. 2, line 56) which includes the claimed 0.9% NaCl (154mM), 0.01-2% BSA (p. 3, line 6), 0.1-1% Tween 20 (p. 2, line 57, and 0.01-0.1% sodium azide (p. 3, line 7). The specific concentrations of components in the first and second reagent claimed all fall within these disclosed ranges.
However, Aimin does not disclose a kit containing 335nm latex particles directly coated with an antibody against Myxovirus Resistance Protein 1 (MxA).
Horisberger’s general disclosure relates to a kit containing latex particles coated with anti-MxA antibodies. Horisberger further discloses the inclusion of “buffer solutions…polypeptides, and detergents” in the kit (col. 21, lines 60-61). Horisberger discloses an antibody (col. 16, lines 7-10) that recognizes a human protein induced by interferon α, is 78 kDa, and has the following N-terminal sequence (col. 3, lines 1-26):
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One skilled in the art would recognize this protein as human Mycovirus Resistance Protein 1 (“MxA”) (https://www.ncbi.nlm.nih.gov/nuccore/NG_027788.2). Horisberger discloses the use of this antibody on antibody-coated latex particles (col. 21, lines 44-45) for the quantitative determination of the protein (col. 21, lines 40-43) and a kit containing these coated particles (col. 21, lines 54-56). Horisberger discloses anti-MxA antibodies from a murine source (col. 16, lines 13-15) and that these antibodies are coated onto the surface of particles (col. 21, lines 44-45).
Regarding claim 3, Horisberger discloses latex particles coated with anti-MxA antibodies (col. 21, lines 44-45). Horisberger further discloses the inclusion of “buffer solutions…polypeptides, and detergents” (col. 21, lines 60-61) for the use of these antibodies with latex agglutination assays (col. 21, lines 40-45) in the kit. These anti-MxA antibodies are considered to be directly covalently coupled to the latex particle because, as evidenced by Bolivar, the attachment of molecules, such as antibodies, to latex particles for use in latex particle immunoassays are routinely directly attached via covalent coupling (p. 494, lines 1-4).
It would have been obvious to one of ordinary skill in the art to modify the kit taught by Aimin by substituting the sensitized latex particles taught by Aimin for the MxA antibody-coated latex particles taught by Horisberger. An artisan would have been motivated to make this modification in order to detect “valuable indicators of the cell response to interferon therapy”, as taught by Horisberger (col. 2, lines 32-36). An artisan would have had a reasonable expectation of success because the reagents in the kit taught by Aimin and the antibody-coated latex particles taught by Horisberger are both intended to be used for latex immunoturbidity assays. Although the latex particles taught by Aimin include BSA as a linker and the particles taught by Horisberger does not, an artisan would expect success in using the particles taught by Horisberger because, as taught by Bolivar, when functionalizing latex particles for use in latex immunoturbidity assays by chemical conjugation, direct covalent attachment to the latex particle allows for long-term immunoreactivity (p. 511, lines 19-22).
However, the combination of Aimin and Horisberger does not teach latex particles having 335nm in diameter.
Regarding claim 3, Thermo discloses the use of latex beads for use in assays with a size range of 300 to 500nm (p.4, para. 4, lines 1-3). Thermo discloses that the use of latex beads this size is good for visibility, to facilitate rapid diffusion, and provide a sufficiently large area for protein adsorption (p.4, para. 4, lines 1-3).
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 kit taught by the combination of Aimin and Horisberger by changing the latex particle size to be between the range of 300 to 500nm, including 335nm, as taught by Thermo. Doing so would be considered combining prior art elements according to known methods to yield predictable results (See MPEP 2413(I)(A)). An artisan would have a reasonable expectation of success because the latex particle sizes described by Thermo are directed to assays as described by Aimin.
Response to Arguments
Applicant's arguments filed 12/29/2025 have been fully considered but they are not persuasive for the following reasons:
Regarding the remarks on pages 5 and 6 on the rejection of claims 2 and 3 under 35 U.S.C. 103, Applicant argues that the inclusion of the protein, BSA, on the latex particle surface as a linker would prohibit an artisan from using the reagent compositions with the directly-conjugated antibody-coated latex particle taught in Horisberger.
This argument is not persuasive. The chemical reagents, R1 and R2, taught in Aimin are directed to the use of latex particles in a latex immunoturbidity assay (p. 2, line 30). Although the latex of Aimin is sensitized in a different method than the latex of Horisberger, an artisan would have a reasonable expectation using the buffers taught by Aimin with the latex of Horisberger because they are both directed toward the use in the same latex immunoturbidity assays.
Further regarding the remarks on page 6, Applicant argues that Aimin does not teach direct coupling of the antibody to the latex particle; therefore, a PHOSITA would not expect that the chemical reagents would function properly with a latex particle with direct conjugation. Although the latex of Aimin is sensitized in a different method than the latex of Horisberger, an artisan would have a reasonable expectation using the buffers taught by Aimin with the latex of Horisberger because they are both directed toward the use in the same latex immunoturbidity assays. Although the reagents, R1 and R2, have been optimized for the latex particles in Aimin, an artisan would have a reasonable expectation of success using the reagents with a directly-conjugated latex particle, even if it is not the optimal set of buffers. Further, as evidenced by CN 109116022A “Kit for detecting lipoprotein phospholipase A2”, which teaches that buffers (p. 2, lines 16-31) similar to the ones taught by Aimin can be used for latex immunoturbidometric assays with directly-conjugated latex particles.
Regarding the remarks on page 7, Applicant argues that claims are not obvious over the prior art due to the amendments requiring direct coupling of the antibody to the latex particles. As described above and in the rejection under 35 U.S.C., claim 3 is rendered obvious by the prior art.
Further regarding the remarks on page 7, Applicant argues that Thermo does not render the 335nm particle size as obvious because it does not reference the noted impact on repeatability or linear range. In response to applicant's argument that the claimed particle size improves assay repeatability and linearity, the fact that the inventor has recognized another advantage which would flow naturally from following the suggestion of the prior art cannot be the basis for patentability when the differences would otherwise be obvious. See Ex parte Obiaya, 227 USPQ 58, 60 (Bd. Pat. App. & Inter. 1985). In this case, the size range suggested by Thermo would render the limitation of a 335nm latex particle diameter obvious even if Thermo does not recognize the described improvement in assay repeatability and linearity. An artisan would select latex particles within the size range taught by Thermo, including 335 nm, to make the particles taught by Horisberger because particles of this size have advantages for visibility, diffusivity, and surface area, regardless of whether they recognize the presence of any additional benefits, such as improved linearity and repeatability.
Conclusion
No claims are allowable.
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/C.E./Examiner, Art Unit 1677
/BAO-THUY L NGUYEN/Supervisory Patent Examiner, Art Unit 1677 January 26, 2026