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 .
DETAILED ACTION
Acknowledgement is hereby made of receipt and entry of the communication filed on Feb. 20, 2026. Claims 1-10 are pending. Claims 2, 4-8 and 10 are withdrawn. Claims 1, 3 and 9 are currently examined.
(Note: claim 7 should be listed as “withdrawn”).
Claim Objections
(Previous objection- withdrawn) Claims 1, 3, and 9 are objected to because of the following informalities:
These claims recite abbreviations “N” protein, “S” protein, “S-NTD” and “S-RBD” without spelling it out the first time it appears in the claims set.
This objection is withdrawn in view of the amendment filed on Feb. 20, 2026.
Claim Rejections - 35 USC § 112 (b)
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.
(Previous rejection- withdrawn) Claims 1, 3 and 9 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out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.
This rejection is withdrawn in view of the clarification in the Remarks filed on Feb. 20, 2026.
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.
(New Rejection-necessitated by amendment) Claims 1, 3 and 9 are rejected under 35 U.S.C. 103 as being unpatentable over Wang et al. (bioRxiv preprint doi: https://doi.org/10.1101/2020.03.26.994756; this version posted April 13, 2020, hereinafter, “Wang”) in view of Shachar et al. (CA3093147A1, published on Nov. 17, 2020, priority date: Dec. 13, 2019, hereinafter, “Shachar”).
The base claim 1 is directed to a kit for detecting multiple antibody biomarkers of interest in a sample, the kit comprising, in one or more vials, containers, or compartments: a. a surface comprising multiple antigens wherein each of the multiple antigens is immobilized on a single distinct binding domain of the surface and the multiple antigens is (ii) an N protein from SARS-CoV-2, an S-RBD from SARS-CoV-2, and an S protein from SARS-CoV-2, and b. a labeled ACE2 protein.
Wang teaches that SARS-CoV-2 proteome peptide microarray that enables high throughput antibody screening of COVID-19 patients to all SARS-CoV-2 protein sequences at amino acid resolution (See page 4, paragraph 2), and the antibody response to SARS-CoV-2 proteins can help identify biomarkers that can be used to detect and treat COVID-19 infection (See Abstract; Figure 1 and Figure 1a below), where the sample is serum (See page 5, paragraph 2), and the microarray is printed on to a 3D modified slide surface (See page 5, paragraph 1).
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For the multiple antigens at “an N protein from SARS-CoV-2, an S-RBD from SARS-CoV-2, and an S protein from SARS-CoV-2” as claimed, Wang teaches that they produce a SARS-CoV-2 proteome microarray and prepared a peptide library containing 966 peptides representing SARS-CoV-2 proteins, in which each peptide is 15 amino acids long with a 5 amino acid overlap. All peptides are labeled with a C-terminal biotin group and printed onto a 3D-modified microscope slide using biotin-streptavidin chemistry. Full-length SARS-COV-2 N protein, full-length E, and five S truncated proteins are also printed (See page 4, paragraph 3; page 5, paragraph 1), which indicates that Wang teaches the antigens that are immobilized on the 3D slide surface as claimed. In the details of S-RBD, Wang teaches the five S truncated protein covering the S-RBD regions (See Table A below, created by the examiners based on the supplementary Table of Wang). Wang teaches that the amino acid residues of S-proteins RBD is 431-505 aa. (See page 15, paragraph 1) and the peptides they designed in Table A shows the peptides covers the S protein regions from amino acid 431 to amino acid 505. Therefore, Wang teaches the S-RBD as claimed as well. Ace2 l
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Also, Wang teaches that the SARS-CoV-2 RBD can bind faster to the ACE2 receptor than the SARS-CoV-1 RBD, thus resulting in high transmission efficiency of the virus (See page 4, paragraph 1) and the SARS-COV-2 S-protein’s RBD (residue 438-498) directly engages the ACE2 receptor and might be an ideal target for developing neutralizing antibodies (See page 8, paragraph 2). Wang includes the ACE2 detection to show that that the epitope is located in the RBD loop engaged with the ACE2 receptor (See page 8, paragraph 2; Figure 4C). Because the S-RBD can bind to the ACE2, therefore, here the S-RBD can be considered as a ACE2 detection agent.
Although Wang does not explicitly point out a kit, it is reasonable to consider that the microarray of Wang et al. encompasses a kit because it includes a 3D slide as a container or compartment, also Wang et al. teaches a detailed method for how to make and use the proteome microarray.
Nevertheless, the concept of packaging components into a kit is well known and routine in the art. For example, Wang et al. disclosed a detailed method for how to prepare and use the SARS-CoV-2 Proteome Microarray, it would have been obvious to one of ordinary skill in the art at the time the invention was made to package components into a kit. One would be motivated to do this for commercial exploitation of the invention by providing convenience for the end user. Thus, the claimed invention is obvious over Wang’s study. According to MPEP § 2112.01(III), “Where the only difference between a prior art product and a claimed product is printed matter that is not functionally related to the product, the content of the printed matter will not distinguish the claimed product from the prior art. In re Ngai, ** > 367 F.3d 1336, 1339, 70 USPQ2d 1862, 1864 (Fed. Cir. 2004) < (Claim at issue was a kit requiring instructions and a buffer agent. The Federal Circuit held that the claim was anticipated by a prior art reference that taught a kit that included instructions and a buffer agent, even though the content of the instructions differed.). See also In re Gulack, 703 F.2d 1381, 1385-86, 217 USPQ 401, 404 (Fed. Cir. 1983) (“Where the printed matter is not functionally related to the substrate, the printed matter will not distinguish the invention from the prior art in terms of patentability…. [T]he critical question is whether there exists any new and unobvious functional relationship between the printed matter and the substrate.”).”
Accordingly, Wang et al. teaches an array kit for detection multiple antibody biomarkers from human serum samples and the kit includes a container (3D slide), multiple antigens of an N protein from SARS-CoV-2, an S-RBD from SARS-CoV-2, and an S protein from SARS-CoV-2. Also, Wang et al. teaches detecting ACE2 though the S-protein-ACE2 protein complex. At the same time, this claim also teaches claim 3 and 9.
As for the newly added limitation in the base claim 1 (b) at “a labeled ACE2 protein”, Wang teaches an epitope on the RBD (FRKSN) recognized by potential neutralizing antibody in S-protein-ACE2 protein complex (See Figure 6, page 2245), however, it is silent on the labeled ACE2 protein.
Shachar teaches an automated, cloud-based, point-of-care (poc) pathogen and antibody array detection system and method where the microarray has been provided with DNA spots of receptor binding domain (RBD) of spike protein, the step of selectively probing the second portion of the sample for antibodies corresponding to the at least one selected virus using the microarray includes the steps of: performing a neutralizing antibody assay using the microarray provided with DNA spots of receptor binding domain (RBD) of spike protein and fluorophore labelled ACE2 and another fluorophore labelled secondary antibody against human lgG for detection of RBD antibody; washing the microarray; drying the microarray. The step of reading the microarray using a fluorescent camera to identify antibodies in the second portion of the sample generates a color image of the microarray with at least two different colors, one color for RBD antibody present in the second portion of the sample and a second color for ACE2, the second portion of the sample without neutralizing antibodies or RBD antibodies being detected with ACE2 fluorescence, while samples with RBD antibodies or increasing amount of neutralizing antibodies that interfere with ACE2-RBD binding being detected with a decreasing amount of ACE2 fluorescence. In the absence of RBD antibodies, the amount of ACE2 fluorescence can be quantified for relative neutralizing activity. The method further includes the step of communicating the color image of the microarray to the cloud for analysis and/or data processing (See Abstract; [21]). Shachar also discloses that the automated method can reduce false negatives and increase sensitivity and specificity for Covid-19 detection (See e.g., page 44, claim 6).
It would have been prima facie obvious for one having ordinary skill in the art before the effective filing date of the claimed invention to introduce the fluorophore labelled ACE2 into Wang’s study to add the second color detection for ACE2. One of skill in the art would have been motivated to do so to introduce the labeled RBD and ACE system to increase the detection sensitivity and specificity. There would be a reasonable expectation of success to develop a kit for detecting multiple antibody biomarkers of interest in a sample comprising the labeled ACE2 protein.
Responses to Applicant’s Remarks
Applicant’s arguments filed on Feb. 20, 2026 has been received and fully considered.
1). Applicant’s amendment for the claim objection is considered. The objection is withdrawn.
2). Applicant’s argument for the rejection under 35 U.S.C § 112(b) is considered. The rejection is withdrawn.
3). Applicant’s argument on the rejection under 35 U.S.C. § 103 is not found persuasive.
(i). Applicant argued that Wang does not teach the “labeled ACE2 protein” (See Remarks, page 17).
This argument is not persuasive.
A new prior art is cited in the current office action based on the new amendment so that Wang in view of Shachar teaches the new limitation of the “labeled ACE2 protein”. In addition, the instant application does not recite a limitation of “competitive serology assay” as argued.
(ii). Applicant argued that Wang does not describe or suggest a single peptide encompassing the full "SRBD" immobilized in its microarray, along with the full-length N protein and S protein, as featured in the present claims (See Remarks, page 17).
This argument is not persuasive.
Wang teaches that peptides were immobilized on the slide via their C-terminus.
Full-length SARS-CoV-2 N protein, full-length E, and five S truncated proteins were also printed (See page 2241, left column). In addition, the instant application does not recite a limitation of “full-length N protein and S protein” as argued.
(iii). Applicant argued that the present claims are non-obvious in view of their commercial success and recognition by others (See Remarks, page 17).
This argument is not persuasive.
Wang listed the challenge and needs for developing SARS-COV-2 diagnostic tests in the introduction (See page 2238), and stated that they use a peptide-based SARS-CoV-2 peptide microarray to analyze antibody interactions in high throughput at the amino acid resolution (See bridging pages 2238-2239).
Conclusion
No claims are allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any extension fee pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RUIXUE WANG whose telephone number is (571)272-7960. The examiner can normally be reached Monday-Friday 8:00 am-5:00 pm, EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Thomas J. Visone can be reached on (571) 270-0684. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/RUIXUE WANG/ Examiner, Art Unit 1672
/THOMAS J. VISONE/ Supervisory Patent Examiner, Art Unit 1672
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