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 .
Response to Amendment
The Amendment filed 03/30/2026 in which claims 1-12 were amended, new claim 13 was added, has been entered.
Claims 1-10, 12-13 are under examination on the merits.
Specification
(Previous objection, withdrawn) Applicant’s amendments to the Specification have overcome the objection previously set forth in the Non-Final Office Action mailed on 12/29/2025.
Claim Objections
(Previous objections, withdrawn as to claims 1-3, 6-10, 12) Applicant’s amendments to claims 1-3, 6-10, 12 have overcome previous objections to those claims.
(New objections, necessitated by amendment as to claims 1, 3, 6, 8) Claims 1, 3, 6, 8 are objected to because of the following informalities:
On claims 1 and 6 the recitation of “for detecting SARS-CoV-2 antigen protein” on line 1 should read “for detecting a SARS-CoV-2 antigen protein”. Further recitations referring to the same SARS-CoV-2 antigen protein should include the definite article “the”. Further, the recitation of “wherein the receptor and antibody” should read “wherein the receptor and the antibody”.
On claims 3 and/or 8 the recitation of 1) “wherein the antibody capable of specifically binding to antigen protein” should read ““wherein the antibody capable of specifically binding to the antigen protein”; 2) “an antibody that recognize” should read “an antibody that recognizes”; 3) “wherein the antibody capable of specifically binding to the antigen protein comprise” should read ““wherein the antibody capable of specifically binding to the antigen protein comprises”.
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.
(Previous rejection, withdrawn as to claims 1-10, 12) Claims 1-10, 12 were rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to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.
See claims as submitted on 03/30/2026.
Applicant’s amendment to the instant claims filed on 03/30/2026 has overcome the previous rejections to claims 1-10, 12.
(New rejection, necessitated by amended as to claims 1-10, 12-13) Claims 1-10, 12-13 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.
See claims as submitted on 03/30/2026.
Amended claims 1 and 6 recite “an antibody capable of specifically binding to SARS-CoV-2 spike antigen protein and conjugated to a visibly identifiable nanostructure” and “an antibody capable of specifically binding to the antigen protein and conjugated to a visibly identifiable nanostructure”, respectively. These recitations appears to have a grammatical error which renders the claims unclear. Specifically, it is unclear what is conjugated to a visibly identifiable nanostructure, the antibody or the antigen. The dependent claims do not provide additional clarity. For purposes of compact prosecution and applying prior art, claims 1, 6 were herein interpreted as referring to the antibody or the antigen conjugated to a visibly identifiable nanostructure. Accordingly, one of ordinary skill in the art will not know the metes and bounds of the claim.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
(New rejection, necessitated by amended as to claims 3 and 8) Claim 3 and 8 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claim 1. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Claims 3 and 8 recite “wherein the antibody capable of specifically binding to the antigen protein comprise any one selected from the group consisting of an antibody that recognize any one of S1, RBD (Receptor binding domain) and RBM (Receptor binding motif) as an antigen”. However, claim 1 as amended requires that the receptor and the antibody bind to the antigen protein at different locations. The RBM and the RBD of a spike protein lie within the S1 domain of the spike protein and, as their names indicate, are locations where the ACE2 receptor binds, therefore the recitation indicated above requiring that the antibody recognizes the S1 domain, the RBD or the RBM fails to include the limitation in claim 1 which requires that the receptor and the antibody bind to the antigen protein at different locations. For purposes of compact prosecution and applying prior art, claims 3 and 8 were herein interpreted consistent with independent claim 1 as referring to an antibody capable of specifically binding to an antigen protein, with the receptor and the antibody binding to the antigen protein at different locations.
Claim Rejections - 35 USC § 102
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 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.
(Previous rejection, maintained and modified as necessitated by amendment as to claims 1-10, 12, expanded as to new claim 13) Claims 1-10, 12-13 are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by US PG Pub 20210190797 A1 to Messing et al. filed on 02/19/2020. See PTO-892: Notice of References Cited.
See claims 1-10, 12-13 as submitted on 03/30/2026.
Regarding claims 1 and 6, it is noted that the amended claims recite two new limitations. First, the limitation of an antibody capable of specifically binding to the antigen protein, wherein a visibly identifiable nanostructure is conjugated to the antibody or the antigen (see also rejections under 35 USC § 112 (b) above); and second, “wherein the receptor and antibody bind to the antigen protein at different locations, respectively”. However these limitations are already taught by Messing et al as outlined below. To reiterate, Messing et al. teach compositions for detecting SARS-CoV-2 and/or diagnosing SARS-CoV-2 infection comprising a lateral flow immunoassay with the following elements (Abstract, ¶¶ [0032], [0083], [0021]-[0024]):
a receptor capable of binding to SARS-CoV-2 spike protein comprising ACE2, wherein the ACE2 receptor binds to the receptor binding domain (RBD) in the S1 domain of the spike protein (¶¶ [0005], [0128])
an antibody capable of binding to SARS-CoV-2 spike protein at the S2 domain (¶¶ [0128], [0137], [0139], SEQ ID NO:32)
wherein the antibody is conjugated to a visibly identifiable label comprising a fluorescent, a radioactive, a chemiluminescent label, a heavy metal such as gold label, a nanoparticle, a bead or an enzymatically active label (¶¶ [0158], [0160])
Regarding claims 2 and 7, it is noted that no new limitations were introduced to claims 2 and 7 in the amendment filed on 03/30/2026. As previously explained, Messing et al. teach a receptor capable of binding to SARS-CoV-2 spike protein comprising an ACE2 receptor (¶ [0128]).
Regarding claims 3 and 8, it is noted that no new limitations were introduced to claims 3 and 8 in the amendment filed on 03/30/2026. As previously explained, Messing et al. teach wherein the antibody binding to SARS-CoV-2 spike protein comprises an antibody that recognizes the S2 domain of a spike protein (¶¶ [0128], [0137], [0139], SEQ ID NO:32) (Messing et al. SEQ ID NO: 1; ¶ [0128]). See also rejections under 35 USC § 112 (d) above.
Regarding claims 4 and 9, it is noted that no new limitations were introduced to claims 4 and 9 in the amendment filed on 03/30/2026. As previously explained, Messing et al. teach wherein the nanostructure comprises gold nanoparticles (¶¶ [0076], [0077], [0158]).
Regarding claims 5 and 10, it is noted that no new limitations were introduced to claims 5 and 10 in the amendment filed on 03/30/2026. As previously explained, Messing et al. teach wherein a sample comprises blood (¶ [0025]).
Regarding claims 12 and 13, it is noted that no new limitations were introduced to claim 12 in the amendment filed on 03/30/2026. Messing et al. further teach a kit comprising the composition of claims 1 and 6 and directions for use (¶ [0031], [0082]-[0089]). It is further noted that 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." ).”
Response to Arguments
Applicant's arguments filed 03/30/2026 have been fully considered but they are not persuasive.
Applicant contends on page 7 of the Remarks submitted on 03/30/2026:
“Messing is focused on serology (antibody detection), not antigen detection and does not disclose or suggest this combination. Specifically, Messing is directed to serological assays for SARS-CoV-2 infection, primarily detecting antibodies (IgA, IgG, IgM) to the S1 spike protein or RBD, using ELISA, dot blot, western blot, lateral flow, etc., but fails to teach or suggest the combination of a receptor (such as ACE2) and an antibody, both binding to different locations on the SARS-CoV-2 spike protein to detect the antigen. Further, the use of a visibly identifiable nanostructure conjugated to the antibody in the sandwich format for antigen detection is not disclosed in Messing. Accordingly, Messing fails to teach each and every element of claim 1 and claim 6, and any of the remaining claims directly or indirectly referring to claim 1 or 6, as required for anticipation under 35 USC § 102(a)(1).
In response:
The disclosure of Messing et al. is not limited to detection of antibodies, and it extends to SARS-CoV-2 antigens (¶ [0135]). Further, as indicated above, Messing et al. already teach an ACE2 receptor which binds at the S1 domain of a spike protein and an antibody capable of specifically binding to SARS-CoV-2 spike protein at the S2 domain, which constitute different binding locations (¶¶ [0128], [0137], [0139], SEQ ID NO:32). Further, as indicated above, Messing et al. teach the use of a visibly identifiable nanostructure conjugated to the antibody. To conclude, Messing et al. teach each and every element of claims 1 and 6, as well as their dependent claims as explained above in detail.
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 MARLENE V BUCKMASTER whose telephone number is (703)756-5371. The examiner can normally be reached M-R 8:00 AM - 5:00 PM.
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/MARLENE V BUCKMASTER/Examiner, Art Unit 1672
/NICOLE KINSEY WHITE/Primary Examiner, Art Unit 1672
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