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
1. 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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 6/16/2026 has been entered.
Status of the Claims
2. Claims 1-29 are the original claims filed 12/2/2020. In the Preliminary Amendment of 12/2/2020, Claims 1-24 are amended and claims 25-29 are canceled. In the Response of 10/30/2023, Claims 1-9 are amended, claims 13 and 15-24 are canceled, and new claims 30-35 are added. In the Response of 3/21/2024, Claims 1-6, 8, 10-12, 30-31, 33, and 35 are amended, claims 7 and 9 are cancelled, and new claims 36-39 are added. In the Preliminary Amendment of 8/14/2024, Claims 2-6, 8 and 36 are amended, Claims 1, 10-12, 14, 30-35, and 37-39 are cancelled, and new Claims 40-44 are added. In the Response of 11/19/2024, Claims 6, 8, 36, and 40 are amended and Claims 2, 3, 4, and 44 are cancelled. In the Response of 4/14/2025, claim 40 is amended and claim 5 is canceled. In the Response 8/5/2025, Claims 40-42 are amended, claims 6, 8 and 36 are canceled and new claims 45-49 are added. In the Response of 1/8/2026, claim 40 is amended and claims 45-49 are canceled. In the RCE of 6/16/2026, no claims are presented for further consideration.
Claims 40-43 are pending.
This Office Action contains new grounds for objection and rejection rejection.
Priority
3. USAN 15/734,301, filed 12/02/2020, and having 4 RCE-type filing therein is a National Stage entry of PCT/EP2019/064428, International Filing Date: 06/04/2019,
PCT/EP2019/064428 Claims Priority from Provisional Application 62/682,795, filed 06/08/2018.
Information Disclosure Statement
4. As of 7/21/2026, a total of four (4) IDS are filed: 12/3/2020; 11/20/2023; 1/8/2026; and 6/16/2026. The corresponding initialed and dated 1449 is considered and of record.
New Grounds for Objection
Claim Objections
5. Claim 40 is objected to because of the following informalities:
Amend claim 40(iv) to insert a space between “13,15.”
Appropriate correction is required.
New Grounds for Rejection
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.
6. Claims 40-43 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.
Claims 40-43 are indefinite because the claims fail to provide any frame of reference that would allow one of skill in the art to unambiguously identify the amino acid(s) referred to the VH of SEQ ID NO:1 and the VK of SEQ ID NO:2. Antibody amino acid sequences are not numbered consistently in the art and can be numbered by linear position or using art recognized antibody numbering indexes, for example, Dondelinger et al (Frontiers in Immunology 9(2278): 1-15, 2018; PTO 892) teaches that position can vary depending on the antibody and the numbering system used, e.g., Sequence-based numbering schemes, such as Kabat, EU and IMGT, structure-based numbering schemes such as Chothia, Martin, Gelfand, AbM, AHo. Accordingly, the metes and bounds of the claimed amino acid(s) cannot be unambiguously construed.
Conclusion
7. No claims are allowed.
8. The sequence of SEQ ID NO:1 (V4L; R48K, _83S; S96T; A54G; N101T; and Y52W) and SEQ ID NO: 2 (A2Q; S20T; S46P, Q52L and P69S) is free from the art and enabled by the specification.
The sequence for each of SEQ ID NOS: 1, 2, 12, 13, 15 and 17 is free from the art.
9. Any inquiry concerning this communication or earlier communications from the examiner should be directed to LYNN A. BRISTOL whose telephone number is (571)272-6883. The examiner can normally be reached Mon-Fri 9 AM-5 PM.
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, Wu Julie can be reached on 571-272-5205. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/LYNN A BRISTOL/Primary Examiner, Art Unit 1643
Prosecution Insights