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 1-58 are the original claims filed 11/17/2022. In the Preliminary Amendment of 5/10/2023, Claims 3-5, 7, 9, 11, 13, 16-17, 19, 21, 23, 25, 28-29, 31, 33, 35, 37, 39-48, and 50-58 are canceled. In the Response of 5/3/2026, claims 14-15 and 38 are amended, canceled claim 16 is re-instated, canceled claims 43-44 are reinstated and amended, claims 1-2, 6, 8, 10, 12, 18, 20, 22, 24, 26-27, 30, 32, 34, 36, 49 are canceled and new claims 59-63 are added. In the Response of 8/4/2026, claims 14-15 and 38 are amended, and claims 16 and 43-44 are canceled. As new claims 59-63 were entered for the claim set of 5/3/2026, those claims are amended herein by Examiner’s Amendment to change the status from new to previously presented.
Claims 14-15, 38, and 59-63 are the claims.
Applicants amendment of the claims raises new grounds for objection and rejection. The Office Action is final.
Priority
2. USAN 18/056,648, filed 11/17/2022, Claims Priority from Provisional Application 60/280,834, filed 11/18/2021.
Information Disclosure Statement
3. As of 9/17/2026, a total of three (3) IDS are filed: 5/12/2023; 6/14/2024; and 6/14/2024. The corresponding initialed and dated 1449 form is considered and of record.
Withdrawal of Objections
Specification
4. The objection to the disclosure because of informalities is withdrawn. Both clean substitute specification and a marked-up copy are provided.
a) The specification is amended to rectify the improper use of the term UniProt, NCBI, Alexa, Expi293, GraphPad, DNASTAR, Carterra, FlowCell, which is a trade name or a mark used in commerce.
Withdrawn-in-part/ Maintained-in-part
Claim Objections
5. The objection to Claims 14-15 and 59-63 because of informalities is:
moot for the canceled claims;
withdrawn for claims 14-15, 38, and 59-63 that are amended to recite: “…comprising a variable domain [,] comprising a heavy chain region (VH).”; amended to delete the phrase “ab antigen-binding fragments thereof”; amended to delete the phrase “isolated complementarity determining region (CDR)”; and
maintained for Claims 14-15 and 59-63 that recite “or antibody fragment” that does not reference the antibody of the claimed invention. Amend the claims to recite “antibody fragment thereof.” Applicants have not responded to the objection. The response is incomplete.
Withdrawal of Rejections
Claim Rejections - 35 USC § 112(a)
Written Description
6. The rejection of Claims 1-2, 8, 14-15, 20, 26-27, 38 and 49 under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement is moot for the canceled claims and withdrawn for the pending claims. The claims are directed to a defined and limited genus of anti-IL1RL1 antibodies characterized by: (1) specific disclosed VH sequences (SEQ ID NO: 345; SEQ ID NOs: 304, 305, 315, 320, 360, 364, and 375); (2) variants thereof having at least about 90% sequence identity; and (3) a shared functional property, namely binding to IL1RL1 with a KD of less than 1 nM.
New Grounds for Objection
Claim Objections
7. Claims 14-15, 38, and 59-63 are objected to because of the following informalities:
a) Claim 1 is objected to because the abbreviation IL1RL1 (Interleukin 1 Receptor-Like 1) should be fully defined on the first occurrence in each claim.
b) Claims 14-15, 38, and 59-63 are objected for failing to include “inclusive” language such as “and” or “or” set forth between the final and penultimate elements for claims 14 and 38.
c) Amend claims 59-62 to recite “A [P]pharmaceutical composition” in claim 59 and “The [P]pharmaceutical composition” in claims 60-62.
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.
8. Claims 14-15 and 59-63 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 14-15 and 59-63 are indefinite because generic claim 14 contains two periods: the 1st after “1 nM” and the 2nd after the deleted text from the amendment of 5/3/2026. The POSA cannot ascertain what subject matter is intended or excluded from the claimed invention.
B) Claims 15 and 59-63 are indefinite for failing to depend from another claim. Claims 15 and 63 recite “claim 0.”
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Written Description
9. Claims 14-15 and 59-63 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claims 14-15 and 59-63 are amended to recite “binds IL1RL1 with a kD of less than 1 nM.” Applicants have not identified support in the application as filed for the species of VH domains being correlated with the kD range that is infinite in scope. The support is hypothetical for any cytokine immunoglobulin comprising a KD of less than 1 nM at
[0093] Provided herein are cytokine variant immunoglobulins (e.g., CD40L, TSLP, IL1RL1, IL1RL2) encoding for an immunoglobulin. In some instances, the cytokine immunoglobulin is an antibody. In some instances, the cytokine immunoglobulin is a VHH antibody. In some instances, the cytokine immunoglobulin comprises a binding affinity (e.g., kD) to cytokine of less than 1 nM, less than 1.2 nM, less than 2 nM, less than 5 nM, less than 10 nM, less than 11 nm, less than 13.5 nM, less than 15 nM, less than 20 nM, less than 25 nM, or less than 30 nM. In some instances, the cytokine immunoglobulin comprises a kD of less than 1 nM. In some instances, the cytokine immunoglobulin comprises a kD of less than 1.2 nM. In some instances, the cytokine immunoglobulin comprises a kD of less than 2 nM. In some instances, the cytokine immunoglobulin comprises a kD of less than 5 nM. In some instances, the cytokine immunoglobulin comprises a kD of less than 10 nM. In some instances, the cytokine immunoglobulin comprises a kD of less than 13.5 nM. In some instances, the cytokine immunoglobulin comprises a kD of less than 15 nM. In some instances, the cytokine immunoglobulin comprises a kD of less than 20 nM. In some instances, the cytokine immunoglobulin comprises a kD of less than 25 nM. In some instances, the cytokine immunoglobulin comprises a kD of less than 30 nM.
Actual binding affinity distribution data shown in Figure 17B for the IL1RL1 libraries of the invention is limited in range hence the claimed range is new matter:
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(MPEP 706.03(m) states in part "New matter includes not only the addition of wholly unsupported subject matter, but may also include adding specific percentages or compounds after a broader original disclosure, or even the omission of a step from a method. See MPEP § 608.04 to § 608.04(c). See In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976) and MPEP § 2163.05 for guidance in determining whether the addition of specific percentages or compounds after a broader original disclosure constitutes new matter.”)
Conclusion
10. No claims are allowed.
11. Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
12. 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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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Wu Julie can be reached at 571-272-5205. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/LYNN A BRISTOL/Primary Examiner, Art Unit 1643
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