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 .
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e)
or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. This application is a 371 of PCT/US2021/070436 filed 04/24/2021 which claims benefit of 63/015,223 filed 04/24/2020. Based on the filing receipt, the effective filing date of this application is April 24, 2020 which is the filing date of Application Number 63/015,223 from which the benefit of priority is claimed.
Election/Restrictions
Applicant’s election with traverse of Group I, claims 1-9, in the reply filed on 10/07/2025 is acknowledged. The traversal is on the grounds that there is no burden searching all of the groups as set forth by the examiner. This is not found persuasive because Groups I-V are directed to different categories of invention while lacking the same or corresponding special technical features. Groups I-V lack unity of invention because even though the inventions of these groups require the technical feature of a reagent comprising a matrix, anti-human immunoglobulin antibodies, and human antibodies, this technical feature is not a special technical feature as it does not make a contribution over the prior art in view of Zheng (US 20160115206 A1, published 2016-04-28).
The requirement is still deemed proper and is therefore made FINAL.
Claims 10-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected Groups II-V, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 10/07/2025.
Claims 1-9 are examined herein.
Information Disclosure Statement
The information disclosure statements filed 10/07/2022, 01/23/2024, 09/24/2024, 10/11/2024, and 05/01/2025 have been considered by the examiner.
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 1-3 and 7 are rejected under 35 U.S.C. 102(a)(1) and (a)(2) as being anticipated by Zheng (US 20160115206 A1, published 2016-04-28).
With respect to claim 1, Zheng teaches a calibration and quality control reagent for a serology immunoassay for detection of antibodies to a microorganism in a human biological sample, the reagent comprising: a matrix, anti-human immunoglobulin antibodies, and human antibodies against an antigen of the microorganism, and wherein a complex of the anti-human immunoglobulin antibody and the human antibodies against an antigen of the microorganism is formed (see, e.g., sheet 9 of 9, under “Fig. 19”, and para. [0054]: “contacting the antibody/antigen complex with labeled anti-human antibody (monoclonal mouse anti-human antibody as shown [in Fig. 19]). The labeled anti-human antibody binds to the antibody present in the antibody/antigen complex forming an antigen/antibody/labeled anti-antibody complex, which is then detected thereby detecting the presence of Treponema pallidum antibodies in the sample”, and para. [0056]: “The kit can also comprise suitable positive and/or negative controls, calibration samples”, and para. [0083], and para. [0090]). It is understood that Treponema pallidum is a microorganism (see, e.g., Zheng, para. [0005]).
With respect to claim to claim 2, Zheng teaches the matrix comprises BSA in PBS (see, e.g., para. [0065]).
With respect to claim 3, Zheng teaches the matrix comprises a polymer (see, e.g., para. [0052]: “Suitable solid phases include, for example, any non-aqueous matrix to which the triplet antigen can be bound. Such solid phases are well known in the immunoassay arts, and include, for example, polystyrene plates, polyacrylamides, glass, polysaccharides, polyvinyl alcohol and silicones”).
With respect to claim 7, Zheng teaches the anti-human immunoglobulin antibodies and the human antibodies against an antigen of a microorganism are present in the reagent at a concentration at about 1:1 (see, e.g., sheet 9 of 9, under “Fig. 19”, and para. [0054]). It is understood that the ratio of antibodies in “Fig. 19” of Zheng is about 1:1.
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.
Claims 4-6 are rejected under 35 U.S.C. 103 as being unpatentable over Zheng (cited above), as applied to claims 1-3 and 7, and further in view of Perera, et al. (“Serological assays for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)”, published 2020-03) as evidenced by He, et al. (“Receptor-binding domain of SARS-CoV spike protein induces highly potent neutralizing antibodies: implication for developing subunit vaccine”, published 2004).
Zheng teaches as set forth above, but fails to teach the antigen is at least a portion of the receptor binding domain of S1 subunit from the SARS-CoV-2 spike protein, as in claims 4-6. However, in a journal article on serological assays for SARS-CoV-2, Perera rectifies this deficiency. Perera teaches the antigen is at least a portion of the receptor binding domain of S1 subunit from the SARS-CoV-2 spike protein, as in claims 4-6 (see, e.g., p. 1, under abstract: “We developed an ELISA to detect IgG and IgM antibodies to the receptor-binding domain (RBD) of the spike protein of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)”). He provides evidence that the receptor-binding domain of the spike protein of the SARS coronavirus is of the S1 subunit (see, e.g., p. 773, under “Abstract”: “The antibodies recognized RBD on S1 domain and completely inhibited SARS-CoV infection”).
Zheng and Perera are analogous to the field of the claimed invention because they are both in the field of serological assays. One of ordinary skill in the art before the effective filing date of the application would have found it obvious to use the SARS-CoV-2 antigen of Perera in the reagent of Zheng. An artisan would have been motivated to do so because Perera discloses, “In order to carry out age-stratified population-based sero-epidemiology, it is important to validate serological methods that can be used in such large-scale studies” (see, p. 1, col. 2, para. 2). Perera further discloses, “Such information is crucial in order to assess development of herd immunity and to calibrate our response to this pandemic” (see, p. 1, col. 2, para. 1). An artisan would have had a reasonable expectation of success based on the given disclosures.
Claims 8-9 are rejected under 35 U.S.C. 103 as being unpatentable over Zheng (cited above), as applied to claims 1-3 and 7, and further in view of Wong (EP 0636886 B1, published 2000-08-30).
Zheng teaches as set forth above, but is silent as to the concentration of the antibodies in the calibrator. Zheng fails to teach the anti-human immunoglobulin antibodies and the human antibodies against an antigen of the microorganism are both in a concentration range from about 0.01 wt% to 10 wt%, as in claims 8-9. However, in a European patent specification on a calibrator or control composition for an IgM serology assay, Wong rectifies this deficiency. Wong teaches the concentration of the anti-human immunoglobulin antibodies and the antibodies against the microorganism antigen are about 0.125 wt% and about 1 wt%, respectively, as in claims 8-9 (see, e.g., anti-human immunoglobulin antibodies – para. [0053]: “A solution of monoclonal antibody to human IgM at a concentration of 1.25 mg/ml in 50 mM TRIS buffer”; antibodies against the microorganism antigen – para. [0047]: “rabbit anti-toxoplasma IgG were each concentrated to about 8 to 10 mg/ml”). It is understood that the antibodies are in an aqueous solution, therefore, the converting from mg/mL to wt% requires diving by 10 because 1 mL of an aqueous solution is about 1 g (for example: 10 mg/mL = 1000 mg/ 100 mL = 1 g/ 100 g = 1 wt%).
Zheng and Wong are analogous to the field of the claimed invention because they are both in the field of serology assay calibrators. One of ordinary skill in the art before the effective filing date of the application would have found it obvious to incorporate the concentrations of Wong into the assay of Zheng. An artisan would have been motivated to do so because Wong discloses that combining the positive calibrator at the concentrations disclosed with the serological OPUS assay module leads to the sensitivity and specificity of the assay being within accepted industry standards (see, e.g., para. [0063]). An artisan would have had a reasonable expectation of success based on the given disclosures.
Conclusion
No claims are allowed.
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. He, et al. (“Receptor-binding domain of SARS-CoV spike protein induces highly potent neutralizing antibodies: implication for developing subunit vaccine”, published 2004) provides evidence that the receptor-binding domain of the spike protein of the SARS coronavirus is of the S1 subunit (see, e.g., p. 773, under “Abstract”: “The antibodies recognized RBD on S1 domain and completely inhibited SARS-CoV infection”).
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/MICHAEL CAMERON SVEIVEN/Examiner, Art Unit 1678
/GREGORY S EMCH/Supervisory Patent Examiner, Art Unit 1678