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 .
Claims 1 and 10-15 are pending.
Applicant's election with traverse of that read on (A) a) a light-chain variable region comprising a CDR1 region of SEQ ID NO: 439, a CDR2 region of SEQ ID NO: 440, and a CDR3 region of SEQ ID NO: 441, and b) a heavy-chain variable region comprising a CDRI region of SEQ ID NO: 442, a CDR2 region of SEQ ID NO: 443, and a CDR3 region of SEQ ID NO: 444 as the species of neutralizing binding molecule and (B) GR-type as the particular type of corona virus in the reply filed on March 30, 2026 is acknowledged. The traversal is on the ground(s) that the Examiner has failed to establish that the species lack unity. Mere identification of species without a unity of invention analysis is improper. As the requirement fails to establish a lack of a special technical feature, the Examiner has failed to establish a lack of unity and all species should be examined together.
This is not found persuasive because the species of neutralizing binding molecules 1) to 49) that binds to a spike protein (S protein) on a surface of coronavirus as set forth in claim 1 do not shared a common structure and possess different combination of six CDRs as evidenced in Table 1 of the specification. Upon the allowance of a generic claim, applicant will be entitled to consideration of claims to additional species which are written in dependent form or otherwise require all the limitations of an allowed generic claim. The requirement is still deemed proper and is therefore made FINAL.
Claims 1 and 10-15, drawn to a neutralizing binding molecule that read on (A) a) a light-chain variable region comprising a CDR1 region of SEQ ID NO: 439, a CDR2 region of SEQ ID NO: 440, and a CDR3 region of SEQ ID NO: 441, and b) a heavy-chain variable region comprising a CDRI region of SEQ ID NO: 442, a CDR2 region of SEQ ID NO: 443, and a CDR3 region of SEQ ID NO: 444 as the species of neutralizing binding molecule and (B) GR-type as the particular type of corona virus, are being acted upon in this Office Action.
Priority
Receipt is acknowledged of papers submitted under 35 U.S.C. 119(a)-(d), which papers have been placed of record in the file.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on April 23, 2026, June 13, 2024 and January 23, 2023 have been considered by the examiner and an initialed copy of the IDS is included with this Office Action.
Drawings
The drawings were received on June 15, 2023. These drawings are acceptable.
Nucleotide and/or Amino Acid Sequence Disclosures
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/patents-application- process/filing-online/legal-framework-efs-web), 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 – (A) the amino acid sequences at pages 108 to 144 are not identified by sequence identifier (SEQ ID NO:), See item 1) a) or 1) b) above. (B) The sequences in Table 1 at pages 33 to 36 and Table 2 at pages 39 to 48 are illegible.
Required response – Applicant must provide:
A substitute specification in compliance with 37 CFR 1.52, 1.121(b)(3) and 1.125 inserting the required incorporation-by-reference paragraph, 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 Rejections - Improper Markush Grouping
Claims 1 and 10-15 are rejected on the basis that it contains an improper Markush grouping of alternatives. See In re Harnisch, 631 F.2d 716, 721-22 (CCPA 1980) and Ex parte Hozumi, 3 USPQ2d 1059, 1060 (Bd. Pat. App. & Int. 1984). A Markush grouping is proper if the alternatives defined by the Markush group (i.e., alternatives from which a selection is to be made in the context of a combination or process, or alternative chemical compounds as a whole) share a “single structural similarity” and a common use. A Markush grouping meets these requirements in two situations. First, a Markush grouping is proper if the alternatives are all members of the same recognized physical or chemical class or the same art-recognized class, and are disclosed in the specification or known in the art to be functionally equivalent and have a common use. Second, where a Markush grouping describes alternative chemical compounds, whether by words or chemical formulas, and the alternatives do not belong to a recognized class as set forth above, the members of the Markush grouping may be considered to share a “single structural similarity” and common use where the alternatives share both a substantial structural feature and a common use that flows from the substantial structural feature. See MPEP § 2117.
The Markush grouping of in claim 1 is improper because the alternatives defined by the Markush grouping do not share both a single structural similarity and a common use for the following reasons: the neutralizing binding molecules 1) to 49) have different combination of six CDRs, as evidenced in Table 1 and the sequence listing, and do not share a substantial feature, e.g., same set of CDRs and a common use that flows from the substantial structural feature.
To overcome this rejection, Applicant may set forth each alternative (or grouping of patentably indistinct alternatives) within an improper Markush grouping in a series of independent or dependent claims and/or present convincing arguments that the group members recited in the alternative within a single claim in fact share a single structural similarity as well as a common use.
Claims 10-15 are included in the rejection because they are dependent on rejected claim and do not correct the deficiency of the claim from which they depend.
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)(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, 10-15 are rejected under 35 U.S.C. 102 (a)(2) as being anticipated by US patent No. 12,546,779 (claimed earliest priority to March 23, 2020).
Claim 1 recites a neutralizing binding molecule that binds a spike protein (S protein) on a surface of coronavirus, wherein the binding molecule is 8) a binding molecule comprising a) a light-chain variable region comprising a CDR1 region of SEQ ID NO: 115, CDR2 region of SEQ ID NO: 116 and CDR3 region of SEQ ID NO: 117, and a heavy-chain variable region comprising a CDR1 region of SEQ ID NO: 118, CDR2 region of SEQ ID NO: 119 and CDR3 region of SEQ ID NO: 120.
The ’779 patent teaches a binding molecule, which binds to a spike protein on a surface of SARS-CoV-2 wherein the binding comprises a light-chain CDR regions of LC CDR1, LC CDR2, and LC CDR3, contained in a light-chain variable region in SEQ ID NO: 1935, which comprises the claimed a light-chain variable region comprising a CDR1 region of SEQ ID NO: 115, CDR2 region of SEQ ID NO: 116 and CDR3 region of SEQ ID NO: 117, see reference SEQ ID NO: 1395, sequence alignment below:
OTHER INFORMATION: No.98 LC variable region
Query Match 80.8%; Score 133.3; Length 110;
Best Local Similarity 39.0%;
Matches 30; Conservative 0; Mismatches 0; Indels 47; Gaps 2;
Qy 1 SGSSSNIGNNYVS---------------DNNKRPS------------------------- 20
||||||||||||| |||||||
Db 23 SGSSSNIGNNYVSWYQQLPGTAPKLLIYDNNKRPSGIPDRFSGSKSGTSATLGITGLQTG 82
Qy 21 -------GTWDSSLSAG 30
||||||||||
Db 83 DEADYYCGTWDSSLSAG 99
And a heavy-chain variable region in SEQ ID NO: 1948, which comprises the claimed a heavy-chain variable region comprising a CDR1 region of SEQ ID NO: 118, CDR2 region of SEQ ID NO: 119 and CDR3 region of SEQ ID NO: 120, see reference SEQ ID NO: 1948, sequence alignment below:
OTHER INFORMATION: No.104 HC variable region
Query Match 89.3%; Score 204.4; Length 128;
Best Local Similarity 47.1%;
Matches 41; Conservative 0; Mismatches 0; Indels 46; Gaps 2;
Qy 1 TSGVGVG--------------LIDWDDNKYYTTSLKT----------------------- 23
||||||| ||||||||||||||||
Db 31 TSGVGVGWIRQPPGKALEWLALIDWDDNKYYTTSLKTRLTISKDTSKNQVVLTMTNMDPV 90
Qy 24 ---------IPGFLRYRNRYYYYGMDV 41
||||||||||||||||||
Db 91 DTATYYCARIPGFLRYRNRYYYYGMDV 117
Regarding claim 10, the ‘779 patent teaches that the binding molecule is an antibody or an antigen-binding fragment thereof, see reference claim 2, in particular.
Regarding claim 11, the ‘779 patent teaches that the binding molecule is a monoclonal antibody, see reference claim 3, in particular.
Regarding claim 12, the ‘779 patent teaches that the monoclonal antibody is a chimeric antibody, a humanized antibody, or a human antibody, see reference claim 4.
Regarding claim 13, the ‘779 patent teaches that the antigen-binding fragment is Fab, F(ab′), F(ab′) 2, Fv, dAb, Fd, single-chain antibody fragment (scFv), scFv-Fc, bivalent single-chain antibody fragment, single-chain phage antibody fragment, diabody, triabody, or tetraabody, see reference claim 5.
Regarding claim 14, the ‘779 patent teaches that the binding molecule has neutralizing activity against a mutant virus having a mutation on a site of the spike protein of SARS-COV-2 other than receptor-binding domain (RBD), see reference claim 7.
Regarding claim 15, the ‘779 patent teaches that the binding molecule has neutralizing activity against SARS-COV-2 S-type, L-type, V-type, G-type, GH-type or GR-type, see reference claim 8, in particular.
Thus, the reference teachings anticipate the claimed invention.
Closest Prior art
The prior arts made of record and not relied upon are considered pertinent to applicant's disclosure.
US Patent No. 11,370,828 teaches anti-Coronavirus Antibody comprising a light chain variable region comprising SEQ ID O: 3936 wherein the light chain variable region comprising 3 CDRs that are identical to the claimed CDR1 of SEQ ID NO 103, a CDR2 of SEQ ID NO: 104 and a CDR3 of SEQ ID NO: 105, see sequence alignment below:
Query Match 84.8%; Score 137.3; Length 110;
Best Local Similarity 39.7%;
Matches 31; Conservative 0; Mismatches 0; Indels 47; Gaps 2;
Qy 1 SGSSSNIGSNTVN---------------SNNQRPS------------------------- 20
||||||||||||| |||||||
Db 23 SGSSSNIGSNTVNWYQQLPTTAPKLLIYSNNQRPSGVPDRFSGSKSGTSASLSISGLQSE 82
Qy 21 -------AAWDDSLNGPV 31
|||||||||||
Db 83 DEADYYCAAWDDSLNGPV 100
However, the ‘828 antibody does not teach the claimed heavy chain variable region.
Likewise, US Patent No. 11,634,477 teaches anti-Coronavirus Antibody comprising a light chain variable region comprising SEQ ID O: 567 wherein the light chain variable region comprising 3 CDRs that are identical to the claimed CDR1 of SEQ ID NO 103, a CDR2 of SEQ ID NO: 104 and a CDR3 of SEQ ID NO: 105, see sequence alignment below:
Query Match 84.8%; Score 137.3; Length 110;
Best Local Similarity 39.7%;
Matches 31; Conservative 0; Mismatches 0; Indels 47; Gaps 2;
Qy 1 SGSSSNIGSNTVN---------------SNNQRPS------------------------- 20
||||||||||||| |||||||
Db 23 SGSSSNIGSNTVNWYQQLPGTAPKLLIYSNNQRPSGVPDRFSGSKSGTSASLAISGLQSE 82
Qy 21 -------AAWDDSLNGPV 31
|||||||||||
Db 83 DEADYFCAAWDDSLNGPV 100
However, the ‘477 antibody does not teach the claimed heavy chain variable region.
Species Restriction Withdrawn
Upon reconsideration in view of the elected species binding molecule of 32) is free of prior art, the search and examination has been extended to include binding molecules 1) to 8) in claim 1.
Allowable Subject Matter
SEQ ID NOs: 7-18, 67-72, 85-96, 103-114, 439-444 are free of prior art.
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PHUONG HUYNH whose telephone number is (571)272-0846. The examiner can normally be reached on 9:00 a.m. to 6:30 p.m. The examiner can also be reached on alternate alternative Friday from 9:00 a.m. to 5:30 p.m.
If attempts to reach the examiner by telephone are unsuccessful, the examiner's supervisor, Misook Yu, can be reached at 571-272-0839. The fax phone number for the organization where this application or proceeding is assigned is 571-272-0839.
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/PHUONG HUYNH/ Primary Examiner, Art Unit 1641
Prosecution Insights