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
Status of the Claims
1. Claims 1-23 are all the claims for this application filed on 7/20/2021. In the Reply of 9/12/2024, original Claims 1-23 are all the claims. In the Response of 5/12/2025, claims 1, 2, 7, 9, 10, 14 and 16-23 are amended and new claim 24 is added. In the RCE of 12/12/2025, Claims 1, 2, 4, 19, 20 and 21 are amended and claims 9 and 16 are canceled. In the Response of 3/10/2026, claims 1, 2, 4, 19-20 and 23 are amended, claims 17-18 are canceled, and new claim 25 is added. In the Response After Final Action of 6/16/2026, Claims 4 and 25 are canceled.
Claims 1-3, 5-8, 10-15 and 19-24 are pending.
The finality of the rejection of the last Office action is withdrawn. This Office Action contains new grounds for rejection.
Priority
2. USAN 17/381,145, filed 07/20/2021, and having 1 RCE-type filing therein is a Continuation of PCT/US2020/014617, filed 01/22/2020, PCT/US2020/014617 Claims Priority from Provisional Application 62/838,071, filed 04/24/2019, PCT/ US2020/ 014617 Claims Priority from Provisional Application 62/795,367, filed 01/22/2019.
Information Disclosure Statement
3. As of 6/24/2026, a total of three (3) IDS are filed: 3/14/2022; 7/17/2023; and 12/12/2025. The corresponding initialed and dated 1449 form is considered and of record.
Withdrawal of Rejection(s)
Claim Rejections - 35 USC § 112(d)
4. The rejection of Claims 4 and 25 under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form is moot for the canceled claims.
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.
5. Claims 1-3, 5-8, 10-15 and 19-24 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.
A) Claims 1-3, 5-8, 10-15 and 19-24 fail to provide any frame of reference that would allow one of skill in the art to unambiguously identify the recited amino acid positions referred to in the structure of the claimed antibody. 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 positions cannot be unambiguously construed.
B) Claim 19 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being incomplete for omitting essential steps, such omission amounting to a gap between the steps. See MPEP § 2172.01. The omitted steps are: the steps for increasing production of an IgAm2 dimer. The preamble includes an invention directed to that subject matter without including a step(s) for creating the subject matter.
Conclusion
6. No claims are allowed.
7. 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.
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/LYNN A BRISTOL/Primary Examiner, Art Unit 1643
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