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
The amendment filed May 15, 2026 in response to the Office Action of February 17, 2026 is acknowledged and has been entered.
Claim 3 has been amended.
Claims 97-106 have been added.
Claims 1-3, 6, 7, 20, 23, 29, 32, 73, and 97-106 are currently under consideration as drawn to the elected invention.
As set forth in the Office Action of 02/17/2026, prior art does not teach or suggest the antibodies: 3F2/3F2, 3F2/50A10, 3F2/49A2 (3F2 and derivatives in Table 5); 9D11/9D11, 9D11/67E12, 9D11/67C6, 9D11/67C3, 9D11/68F5, 9D11/67G3, 9D11/67H9 (9D11 and derivatives in Table 7); 39A11/39A11, 39A11/57H3, 39A11/57G8, 39A11/56A9, 39A11/56H7, 39A11/62F9 (39A11 and derivatives in Table 9); 1D3/ID3, 1D3/45A2, 1D3/47B2 (1D3 and derivatives in Table 17).
In view of claim amendments and Applicant’s argument, the 112(a) rejection set forth in the previous Office Action of February 17, 2026 is hereby withdrawn.
Information Disclosure Statement
The Information Disclosure Statement filed on 05/15/2026 has been considered and entered by examiner.
Specification
The disclosure is objected to because of the following informalities: The current application was filed after July 1, 2022, thus the WIPO Standard ST.26, Sequence Listing in XML format, applies to sequence disclosures. See 37 CFR § 1.831. An ST.26 Sequence Listing in XML must not include any sequences having fewer than 10 specifically defined nucleotides, or fewer than 4 specifically defined amino acids. See 37 CFR § 1.831(j).
The specification filed 05/15/2026 refers SEQ ID NO: 74 at least in Table 5, Table 16 and Table 20; SEQ ID NO: 85 at least in Table 5, Table 17 and Table 20; SEQ ID NO:112 at least in Table 7, Table 18 and Table 20; SEQ ID NO:134, SEQ ID NO:135 at least in Table 9, Table 19 and Table 20; SEQ ID NO:176 at least in Table 20 and Table 24; and SEQ ID NO:182 at least in Table 20 and Table 24. These sequences are replaced with “000” in the Sequence Listing in XML because the sequences are less than 4 amino acid sequences. These SEQ ID NOS in the specification should be deleted and replaced with correct sequences because the Sequence Listing in XML does not contain the short sequences.
In addition, the specification of 06/202023 incorporated a paragraph of Sequence Listing. However, the paragraph was deleted in the specification of 05/15/2026. The paragraph should be maintained.
Appropriate correction is required.
Response to Arguments
For the objection to the Specification, Applicant argues:
Applicant respectfully disagrees and submits that the Specification identifies the sequences referred to by the Office by amino acid and SEQ ID NO clearly in the Tables. The WIPO guidance provides that "sequences too short to be included in the sequence listing may be presented in the manner considered most appropriate hv the applicant." See Annex C, Administrative Instructions under the Patent Cooperation Treaty, WIPO (emphasis added). Therefore, Applicant respectfully submits that the sequences have been clearly presented in the Specification, and do not need to be "deleted and replaced with correct sequences" just because the Sequence Listing does not contain the short sequences. Applicant also notes that while ST.26 version l excludes short sequences, ST.26 version 2 (v,foch was approved November 2025 and will be implemented July 2027) will reinstate applicant's ability to optionally include short sequences.
Applicant’s arguments have been fully considered but they are only partially persuasive. In the amended Specification of 05/15/2026, the SEQ ID NOs: 74, 85, 112, 134, 135, 176 and 182 are maintained. These SEQ ID NOs are skipped in Sequence List (XML file), thus, the short sequences (correct sequences) listed in the Tables do not correspond to the recited SEQ ID NOs. To overcome the objection, Applicant can delete the SEQ ID NOs from Specification, but keep the correct sequence description.
Claim Rejections - 35 USC § 112
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.
Claim 3 is 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. The independent claim (claim 1) requires specific, fixed CDR sequences for VH and VL of the claimed antibody or antigen-binding fragment thereof. However, the dependent claim (claim 3) attempts to encompasses a broad 95% sequence identity to the entire VH and VL region. Because “95% sequence identity” allows variations across the variable domain, this variant could mutate the highly specific CDRs defined in the independent claim. If a variant antibody falls into the 95% identity bucket but loses the recited CDR sequences, the dependent claim (claim 3) would effectively be broader than or inconsistent with the independent claim (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.
Conclusion
Claim 3 is rejected.
Claims 1-2, 6, 7, 20, 23, 29, 32, 73, and 97-106 are drawn allowable subject matter.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHENG LU whose telephone number is (571)272-0334. The examiner can normally be reached Monday-Friday 8-5.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Samira Jean-Louis can be reached at (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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/CHENG LU/Examiner, Art Unit 1642
/SAMIRA J JEAN-LOUIS/Supervisory Patent Examiner, Art Unit 1642
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