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
1. Applicant’s election of Group II in the reply filed on 7/20/2026 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Applicant's election with traverse of species (immunochromatography; (1)) in the reply filed on 7/20/2026 is acknowledged.
The traversal is on the ground(s) that: claim 11 recites two types of monoclonal antibodies or antibody fragments thereof which recognize different epitopes; applicant requests examination of a pair and another one which recognizes a different epitope from (1).
Applicant’s request is noted and (2) is added for search and consideration.
The requirement is still deemed proper and is therefore made FINAL.
Claims 1, 5-10 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected Invention, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 7/20/2026.
Claims 11, 15-20 are under consideration.
Priority
2. Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Since a certified English translation has not been provided for JAPAN 2021-100123, until foreign priority is perfected, the effective filing date for the purposes of applying prior art is 6/16/2022.
Information Disclosure Statement
3. The information disclosure statement (IDS) was submitted on 5/16/2025; 1/11/2024. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Nucleotide and/or Amino Acid Sequence Disclosures
4. REQUIREMENTS FOR PATENT APPLICATIONS CONTAINING NUCLEOTIDE AND/OR AMINO ACID SEQUENCE DISCLOSURES
Items 1) and 2) provide general guidance related to requirements for sequence disclosures.
37 CFR 1.821(c) requires that patent applications which contain disclosures of nucleotide and/or amino acid sequences that fall within the definitions of 37 CFR 1.821(a) must contain a "Sequence Listing," as a separate part of the disclosure, which presents the nucleotide and/or amino acid sequences and associated information using the symbols and format in accordance with the requirements of 37 CFR 1.821 - 1.825. This "Sequence Listing" part of the disclosure may be submitted:
In accordance with 37 CFR 1.821(c)(1) via the USPTO patent electronic filing system (see Section I.1 of the Legal Framework for Patent Electronic System (https://www.uspto.gov/PatentLegalFramework), hereinafter "Legal Framework") as an ASCII text file, together with an incorporation-by-reference of the material in the ASCII text file in a separate paragraph of the specification as required by 37 CFR 1.823(b)(1) identifying:
the name of the ASCII text file;
ii) the date of creation; and
iii) the size of the ASCII text file in bytes;
In accordance with 37 CFR 1.821(c)(1) on read-only optical disc(s) as permitted by 37 CFR 1.52(e)(1)(ii), labeled according to 37 CFR 1.52(e)(5), with an incorporation-by-reference of the material in the ASCII text file according to 37 CFR 1.52(e)(8) and 37 CFR 1.823(b)(1) in a separate paragraph of the specification identifying:
the name of the ASCII text file;
the date of creation; and
the size of the ASCII text file in bytes;
In accordance with 37 CFR 1.821(c)(2) via the USPTO patent electronic filing system as a PDF file (not recommended); or
In accordance with 37 CFR 1.821(c)(3) on physical sheets of paper (not recommended).
When a “Sequence Listing” has been submitted as a PDF file as in 1(c) above (37 CFR 1.821(c)(2)) or on physical sheets of paper as in 1(d) above (37 CFR 1.821(c)(3)), 37 CFR 1.821(e)(1) requires a computer readable form (CRF) of the “Sequence Listing” in accordance with the requirements of 37 CFR 1.824.
If the "Sequence Listing" required by 37 CFR 1.821(c) is filed via the USPTO patent electronic filing system as a PDF, then 37 CFR 1.821(e)(1)(ii) or 1.821(e)(2)(ii) requires submission of a statement that the "Sequence Listing" content of the PDF copy and the CRF copy (the ASCII text file copy) are identical.
If the "Sequence Listing" required by 37 CFR 1.821(c) is filed on paper or read-only optical disc, then 37 CFR 1.821(e)(1)(ii) or 1.821(e)(2)(ii) requires submission of a statement that the "Sequence Listing" content of the paper or read-only optical disc copy and the CRF are identical.
Specific deficiencies and the required response to this Office Action are as follows:
Specific deficiency – Nucleotide and/or amino acid sequences appearing in the drawings in Figures 1, 2 are not identified by sequence identifiers in accordance with 37 CFR 1.821(d). Sequence identifiers for nucleotide and/or amino acid sequences must appear either in the drawings or in the Brief Description of the Drawings.
Required response – Applicant must provide:
Replacement and annotated drawings in accordance with 37 CFR 1.121(d) inserting the required sequence identifiers;
AND/OR
A substitute specification in compliance with 37 CFR 1.52, 1.121(b)(3) and 1.125 inserting the required sequence identifiers into the Brief Description of the Drawings, consisting of:
A copy of the previously-submitted specification, with deletions shown with strikethrough or brackets and insertions shown with underlining (marked-up version);
A copy of the amended specification without markings (clean version); and
A statement that the substitute specification contains no new matter.
Claim Objections
5. Claim 20 is objected to because of the following informalities:
As to claim 20, for improved clarity the claim should recite “according to claim 11”.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
6. Claims 11, 15-18, 20 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
See claims 11, 15-18, 20 as submitted 7/20/2026.
Each of the claims is thus drawn, inherently or explicitly, to two types of monoclonal antibodies or antibody fragments thereof that bind to a peptide fragment having 30 or less consecutive amino acids in a nucleocapsid protein of SARS-CoV-2, wherein the two types of monoclonal antibodies or antibody fragments thereof recognize different epitopes, and wherein the peptide fragment having 30 or less consecutive amino acids is a peptide fragment having an amino acid sequence represented by KQQTVTLLPAADLDDFSKQLQQSMSSA (SEQ ID NO: 1). Thus, the claims are drawn to compositions comprising or methods of using a genus of monoclonal antibodies or antibody fragments thereof, and having the ability to bind to a peptide fragment having 30 or less consecutive amino acids in a nucleocapsid protein of SARS-CoV-2, wherein the two types of monoclonal antibodies or antibody fragments thereof recognize different epitopes, and wherein the peptide fragment having 30 or less consecutive amino acids is a peptide fragment having an amino acid sequence represented by KQQTVTLLPAADLDDFSKQLQQSMSSA (SEQ ID NO: 1). Further, dependent claim 17 recites SEQ ID NOs: 2, 3; dependent claim 20 recites SEQ ID NOs: 26, 27. Thus, the claims read on “any” such two types of monoclonal antibodies or antibody fragments thereof that bind as claimed.
The following quotation from section 2163 of the Manual of Patent Examination
Procedure is a brief discussion of what is required in a specification to satisfy the 35 U.S.C. 112 written description requirement for a generic claim covering several distinct inventions:
The written description requirement for a claimed genus may be satisfied through sufficient description of a representative number of species by actual reduction to practice..., reduction to drawings..., or by disclosure of relevant, identifying characteristics, i.e., structure or other physical and/or chemical properties, by functional characteristics coupled with a known or disclosed correlation between function and structure, or by a combination of such identifying characteristics, sufficient to show the applicant was in possession of the claimed genus... See Eli Lilly, 119 F.3d at 1568, 43 USPQ2d at 1406. 'A "representative number of species" means that the species which are adequately described are representative of the entire genus. Thus, when there is substantial variation within the genus, one must describe a sufficient variety of species to reflect the variation within the genus.
Thus, when a claim covers a genus of inventions, the specification must provide written description support for the entire scope of the genus. Support for a genus is generally found where the applicant has provided a number of examples sufficient so that one in the art would recognize from the specification the scope of what is being claimed.
In the present case, the specification teaches: monoclonal antibodies comprising CDRs comprising SEQ ID NOs: 4-6, 7-9; 10-12, 13-15; 16-18, 19-20 (pages 5, 15, 17; Table 9).
However, it is known in the art that even the most minor differences can have significant effects on antigen-antibody binding ability. The art relating to antibodies recognizes that the formation of an intact antigen-binding site generally requires the association of the complete heavy and light chain variable regions of a given antibody, each of which consists of three CDRs which provide the majority of the contact residues for the binding of the antibody to its target epitope. The amino acid sequences and conformations of each of the heavy and light chain CDRs are critical in maintaining the antigen binding specificity and affinity that is characteristic of the parent immunoglobulin. It is expected that all of the heavy and light chain CDRs in their proper order and in the context of framework sequences which maintain their required conformation, are required in order to produce a protein having antigen-binding function and that properassociation of heavy and light chain variable regions is required in order to form functional antigen binding sites. Even minor changes in the amino acid sequences of the heavy and light variable regions, particularly in the CDRs, may dramatically affect antigen-binding function as evidenced by Rudikoff et al. ("Single amino acid substitution altering antigen-binding specificity," Proc Natl Acad Sci USA 79:1979-1983 (1982))(See PTO-892: Notice of References Cited). Rudikoff et al. teaches that the alteration of a single amino acid in the CDR of a phosphocholine-binding myeloma protein resulted in the loss of antigen-binding function.
Therefore, in light of the knowledge in the art, broad scope of the claim reading on any two types of monoclonal antibodies or antibody fragments thereof that bind to a peptide fragment having 30 or less consecutive amino acids in a nucleocapsid protein of SARS-CoV-2, wherein the two types of monoclonal antibodies or antibody fragments thereof recognize different epitopes, and wherein the peptide fragment having 30 or less consecutive amino acids is a peptide fragment having an amino acid sequence represented by KQQTVTLLPAADLDDFSKQLQQSMSSA (SEQ ID NO: 1), and the teachings in the specification, there is still a high level of uncertainty as to which monoclonal antibodies or antibody fragments thereof fall within the scope of the indicated genus.
In view of the fact that the examples provided do not demonstrate possession of the genus encompassing monoclonal antibodies or antibody fragments thereof showing the binding ability as claimed, and that the application has identified no structure correlating with said monoclonal antibodies or antibody fragments’ ability to bind, there is insufficient written description support for the indicated genus of monoclonal antibodies or antibody fragments, and therefore for the methods of using them.
For the reasons above, and in view of the uncertainty as to which monoclonal antibodies or antibody fragments would be able to bind to a peptide fragment having 30 or less consecutive amino acids in a nucleocapsid protein of SARS-CoV-2, wherein the two types of monoclonal antibodies or antibody fragments thereof recognize different epitopes, and wherein the peptide fragment having 30 or less consecutive amino acids is a peptide fragment having an amino acid sequence represented by KQQTVTLLPAADLDDFSKQLQQSMSSA (SEQ ID NO: 1), the application has not provided sufficient written description support for the use of the genus of monoclonal antibodies or antibody fragments identified in claim 11. The application therefore fails to provide adequate support for methods of using this genus of monoclonal antibodies or antibody fragments.
Claim Rejections - 35 USC § 102/103
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 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.
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.
7. Claims 11, 15, 18 are rejected under 35 U.S.C. 102(a)(1) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over Hodge et al. (“Rigid monoclonal antibodies improve detection of SARS-CoV-2 nucleocapsid protein,” bioRxiv Jan 13:2021.01.13.426597.
doi: 10.1101/2021.01.13.426597. [Preprint](2021))(See PTO-892: Notice of References Cited) as evidenced by Buch et al. (WO2021250467A2)(See PTO-892: Notice of References Cited).
See claims 11, 15, 18 as submitted 4/27/2026.
Hodge et al. teaches: monoclonal antibodies that bind different epitopes on NPNTD of SARS-CoV-2 (abstract); LFA (abstract)(as recited in claim 18); LFAs to detect NP in swabs (p. 2)(as recited in claim 15). The claim language “a peptide fragment having 30 or less consecutive amino acids in a nucleocapsid protein of SARS-CoV-2 … wherein the peptide fragment having 30 or less consecutive amino acids is a peptide fragment having an amino acid sequence represented by KQQTVTLLPAADLDDFSKQLQQSMSSA (SEQ ID NO: 1)” is interpreted as nucleocapsid protein “comprising” KQQTVTLLPAADLDDFSKQLQQSMSSA (SEQ ID NO: 1)(See MPEP 2111).
Buch et al. teaches: SEQ ID NO: 88, which comprises sequence with 100% identity with instant SEQ ID NO: 1 (See Result 18 of STIC Sequence Search Result 20260816_112729_us-18-290-089-1.rag in Supplemental Content Tab); as well as determining presence of antibody that binds to portion of nucleocapsid polypeptide SARS-CoV-2 in sample. Buch et al. is cited in support of Hodge et al.’s teaching of SARS-CoV-2 nucleocapsid protein to teach sequence comprising SEQ ID NO: 1.
In view of the foregoing, the claimed kit is within the scope of Hodge et al. as evidenced by Buch et al., and thus Hodge et al. as evidenced by Buch et al. renders the kit as claimed prima facie obvious.
Thus, Hodge et al. as evidenced by Buch et al. anticipates or renders obvious the instant claims.
8. Claims 11, 15, 18 are rejected under 35 U.S.C. 102(a)(1) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over Terry et al. (“Development of a SARS-CoV-2 nucleocapsid specific monoclonal antibody,” Virology 558: 28-37 (2021))(See PTO-892: Notice of References Cited) as evidenced by Buch et al. (WO2021250467A2)(See PTO-892: Notice of References Cited).
See claims 11, 15, 18 as submitted 4/27/2026.
Terry et al. teaches: SARS-CoV-2 specific mBG86 monoclonal antibody and an antibody toolkit for the study of SARS-CoV-2 N protein (p. 29); including mBG17 and mBG86 for use in sandwich ELISA (p. 36), wherein epitope for mBG17 (AA381-419) may be more accessible in N protein derived from infection than the mBG67/86 epitope (AA133-179)(interpreted as recognizing different epitopes as recited in claim 11); wherein N protein has been found in swab samples (p. 29)(as recited in claim 15); for lateral flow assays (p. 29)(as recited in claim 18).
The claim language “a peptide fragment having 30 or less consecutive amino acids in a nucleocapsid protein of SARS-CoV-2 … wherein the peptide fragment having 30 or less consecutive amino acids is a peptide fragment having an amino acid sequence represented by KQQTVTLLPAADLDDFSKQLQQSMSSA (SEQ ID NO: 1)” is interpreted as nucleocapsid protein “comprising” KQQTVTLLPAADLDDFSKQLQQSMSSA (SEQ ID NO: 1)(See MPEP 2111).
Buch et al. teaches: SEQ ID NO: 88, which comprises sequence with 100% identity with instant SEQ ID NO: 1 (See Result 18 of STIC Sequence Search Result 20260816_112729_us-18-290-089-1.rag in Supplemental Content Tab); as well as determining presence of antibody that binds to portion of nucleocapsid polypeptide SARS-CoV-2 in sample. Buch et al. is cited in support of Terry et al.’s teaching of SARS-CoV-2 nucleocapsid protein to teach sequence comprising SEQ ID NO: 1.
In view of the foregoing, the claimed kit is within the scope of Terry et al. as evidenced by Buch et al., and thus Terry et al. as evidenced by Buch et al. renders the kit as claimed prima facie obvious.
Thus, Terry et al. as evidenced by Buch et al. anticipates or renders obvious the instant claims.
Conclusion
9. Claim 19 is objected to for depending on a rejected claim. (1) and (2) in claim 19 are free of the prior art of record.
10. No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to M FRANCO G SALVOZA whose telephone number is (571)272-4468. The examiner can normally be reached M-F 8:00 to 5:00.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Thomas Visone can be reached at 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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/M FRANCO G SALVOZA/Primary Examiner, Art Unit 1672
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