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
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on May 18, 2026 has been entered.
Claim Status
Applicant's amendment filed on March 18, 2026 has been received and entered.
Claims 8-10 and 12-15 have been amended.
Claim 11 was previously canceled.
Claims 1-10 and 12-17 are pending and under consideration.
Priority
This application is a 371 of PCT/KR2021/009655 filed July 26, 2021, which claims the benefit of foreign application REPUBLIC OF KOREA 10-2020-0093382 filed July 27, 2020. Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55. Receipt is acknowledged of the certified English translated copy of the foreign priority document in the reply received May 18, 2025.
Claim Rejections
In view of Applicant’s claim amendments, the previous grounds of rejection under 35 U.S.C. 112(b) have been withdrawn.
Specification
Nucleotide and/or Amino Acid Sequence Disclosures
Specific deficiency - This application fails to comply with the requirements of 37 CFR 1.821 - 1.825 because it does not contain a "Sequence Listing” as a separate part of the disclosure or a CRF of the “Sequence Listing” for one or more nucleic acid sequences.
There are no Sequence Listings for the primer sequences disclosed in Tables 1 and 3-5 of the specification. Each primer sequence with greater than 10 specifically defined nucleotides must be added to the Sequence Listing.
Required response - Applicant must provide:
An updated "Sequence Listing" part of the disclosure; together with
An amendment specifically directing its entry into the application in accordance with 37 CFR 1.825(a)(2);
A statement that the "Sequence Listing" includes no new matter as required by 37 CFR 1.821(a)(4); and
A statement that indicates support for the amendment in the application, as filed, as required by 37 CFR 1.825(a)(3).
If the "Sequence Listing" part of the disclosure is submitted according to item 1) a) or b) above, Applicant must also 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.
If the "Sequence Listing" part of the disclosure is submitted according to item 1) c) or d) above, applicant must also provide:
A CRF in accordance with 37 CFR 1.821(e)(1) or 1.821(e)(2) as required by 1.825(a)(5); and
A statement according to item 2) a) or b) above.
Specific deficiency – Nucleotide sequences appearing in the specification are not identified by sequence identifiers in accordance with 37 CFR 1.821(d). Sequences with 10 or more specifically defined nucleotides require a sequence identifier.
Table 1 - pg. 13
Table 3 - pg. 30
Table 4 - pg. 31
Table 5 - pg. 35
The primer sequences in Tables 1 and 3-5 do not appear in the Sequence Listing and do not have sequence identifiers. The sequence identifiers must be added to the tables upon submission of a new Sequence Listing.
Required response – Applicant must provide:
Amended specification in compliance with 37 CFR 1.52, 1.121(b)(3) and 1.125 inserting the required sequence identifiers, 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 - 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.
Claims 1-10 and 12-17 are rejected under 35 U.S.C. 112(b) 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.
Claims 1, 4, 6, 8, 13, 15, and 17 are drawn to a humanized antibody specific to a Bacillus anthracis protective antigen comprising an amino acid sequence represented by….
Claims 2-3, 5, 7, 12, and 14 are drawn to the antibody nucleic acid represented by a nucleotide sequence of….
The claims recite the protective antigen “comprising” an amino acid sequence, which would limit the claims to whole antibodies. However, the claims also recite “an” amino acid sequence which is open language and would encompass both antibodies and antibody fragments thereof.
Furthermore, the claims also recite the term amino acid sequence “represented by”, which makes the claims ambiguous as to what the representative sequences are. For example, are the amino acid sequence represented by SEQ ID NO: 1 an exemplary example of the antibody VL amino acid sequence, or is the VL limited to SEQ ID NO: 1? As such, one of ordinary skill in the art would not be able to determine the metes and bounds of the claims.
To overcome the rejection, Applicant should amend the claims to read, for example,
“consisting of the amino acid sequence of”; or
“the nucleic acid comprising the nucleotide sequence of”.
Claims 9-10 and 16 are included in the rejection because they depend from a rejected claim and fail to clarify the issue.
Closest Prior Art
There is no prior art that teaches a humanized antibody specific to a Bacillus anthracis protective antigen comprising a light chain consisting of the amino acid sequence of SEQ ID NO: 1 and a heavy chain consisting of the amino acid sequence of SEQ ID NO: 2, further comprising VL CDR1 of SEQ ID NO: 5, CDR2 of SEQ ID NO: 6; and CDR3 of SEQ ID NO: 7; and a heavy chain CDR1 of SEQ ID NO: 8; a CDR2 of SEQ ID NO: 9; and a heavy chain CDR3 of SEQ ID NO: 10.
There is no prior art that teaches or suggests a humanized antibody specific to a Bacillus anthracis protective antigen with the specific sequences as recited in the instant claims. The closest prior art, Ahn et al. (Biochem Biophys Res Commun, 2019; 509:611-616; cited IDS 2/13/2023), teaches an anti-Bacillus anthracis protective antigen antibody, however, does not teach or suggest the presently claimed method with specific sequences.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MAUREEN DRISCOLL whose telephone number is (571) 270-0730. The examiner can normally be reached Monday through Friday.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Samira Jean-Louis can be reached on (571) 270-3503. The fax phone number for the organization where this application or proceeding is assigned is (571) 273-8300.
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/MAUREEN VARINA DRISCOLL/ Examiner, Art Unit 1642
/SAMIRA J JEAN-LOUIS/Supervisory Patent Examiner, Art Unit 1642
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