Office Action 2: Notice of Allowance (2025-01-23)

CLAIMS:
Listing of the Claims

SVG {EMBED HERE} 0.290.267 Dkt No. 09402.002US2 . Ser. No. 17/486,864 AMENDMENTS OF THE CLAIMS Please replace all prior versions of the claims of the application with the following Listing of the Claims. Deleted text is indicated by or by insertion between \[\[double brackets\]\] and inserted text is indicated by underlininq.

1\. (Currently Amended) A method of treating an IL1 RAP mediated disease in a subject, wherein the IL1RAP mediated disease is asthma, comprising administering to the subject a therapeutically effective amount of an antibody, wherein the antibody comprises: (i) a first light chain hypervariable region (HVR-L1), a second light chain hypervariable region (HVR-L2), and a third light chain hypervariable region (HVR-L3), and (ii) a first heavy chain hypervariable region (HVR-H 1), a second heavy chain hypervariable region (HVR-H2), and a third heavy chain hypervariable region (HVR-H3); wherein:(a) HVR-L1 comprises an amino acid sequence of SEQ ID NO: 11;
(b) HVR-L2 comprises an amino acid sequence selected from SEQ ID NO: 37, and 54;
(c) HVR-L3 comprises an amino acid sequence selected from SEQ ID NO: 63, 69, and 70;
(d) HVR-H1 comprises an amino acid sequence of SEQ ID NO: 78;
(e) HVR-H2 comprises an amino acid sequence selected from SEQ ID NO: 191, and 195;
(f) HVR-H3 comprises an amino acid sequence selected from SEQ ID NO: 203 and 215.

2\. (Original) The method of claim 1, wherein the antibody comprises:a first light chain framework region (FR-Li) comprising an amino acid sequence of SEQ ID NO: 244;
a second light chain framework region (FR-L2) comprising an amino acid sequence of SEQ ID NO: 246;
a third light chain framework region (FR-L3) comprising an amino acid sequence of SEQ ID NO: 247; and
a fourth light chain framework region (FR-L4) comprising an amino acid sequence of SEQ ID NO: 248; or

a first heavy chain framework region (FR-H1) comprising an amino acid sequence of SEQ ID NO: 253;
a second heavy chain framework region (FR-H2) comprising an amino acid sequence of SEQ ID NO: 254;
a third heavy chain framework region (FR-H3) comprising an amino acid sequence of SEQ ID NO: 255; and
a fourth heavy chain framework region (FR-H4) comprising an amino acid of SEQ ID NO: 256.

3\. (Original) The method of claim 1, wherein the antibody comprises a light chain variable domain (VL) amino acid sequence having at least 90% identity to SEQ ID NO: 259; and/or a heavy chain variable domain (VH) amino acid sequence having at least 90% identity to SEQ ID NO: 290.

4\. (Original) The method of claim 3, wherein the antibody comprises:the light chain variable domain (VL) amino acid sequence of SEQ ID NO: 259, and the heavy chain variable domain (VH) amino acid sequence of SEQ ID NO: 290;
the light chain variable domain (VL) amino acid sequence of SEQ ID NO: 268, and the heavy chain variable domain (VH) amino acid sequence of SEQ ID NO: 307;
the light chain variable domain (VL) amino acid sequence of SEQ ID NO: 268, and the heavy chain variable domain (VH) amino acid sequence of SEQ ID NO: 298;
the light chain variable domain (VL) amino acid sequence of SEQ ID NO: 269, and the heavy chain variable domain (VH) amino acid sequence of SEQ ID NO: 307;
the light chain variable domain (VL) amino acid sequence of SEQ ID NO: 269, and the heavy chain variable domain (VH) amino acid sequence of SEQ ID NO: 298;
the light chain variable domain (VL) amino acid sequence of SEQ ID NO: 269, and the heavy chain variable domain (VH) amino acid sequence of SEQ ID NO: 297;
the light chain variable domain (VL) amino acid sequence of SEQ ID NO: 270, and the heavy chain variable domain (VH) amino acid sequence of SEQ ID NO: 307; or the light chain variable domain (VL) amino acid sequence of SEQ ID NO: 270, and the heavy chain variable domain (VH) amino acid sequence of SEQ ID NO: 298.

5\. The method of claim 1, wherein the antibody comprises a light chain (LC) amino acid sequence having at least 90% identity to SEQ ID NO: 328; and/or a heavy chain (HC) amino acid sequence having at least 90% identity to SEQ ID NO: 332.

6\. (Original) The method of claim 5, wherein the antibody comprises:the light chain (LC) amino acid sequence of SEQ ID NO: 328, and the heavy chain (HC) amino acid sequence of SEQ ID NO: 332;
the light chain (LC) amino acid sequence of SEQ ID NO: 329, and the heavy chain (HC) amino acid sequence of SEQ ID NO: 335;
the light chain (LC) amino acid sequence of SEQ ID NO: 329, and the heavy chain (HC) amino acid sequence of SEQ ID NO: 336;
the light chain (LC) amino acid sequence of SEQ ID NO: 329, and the heavy chain (HC) amino acid sequence of SEQ ID NO: 333;
the light chain (LC) amino acid sequence of SEQ ID NO: 329, and the heavy chain (HC) amino acid sequence of SEQ ID NO: 334;
the light chain (LC) amino acid sequence of SEQ ID NO: 330, and the heavy chain (HC) amino acid sequence of SEQ ID NO: 335;
the light chain (LC) amino acid sequence of SEQ ID NO: 330, and the heavy chain (HC) amino acid sequence of SEQ ID NO: 336;
the light chain (LC) amino acid sequence of SEQ ID NO: 330, and the heavy chain (HC) amino acid sequence of SEQ ID NO: 333;
the light chain (LC) amino acid sequence of SEQ ID NO: 330, and the heavy chain (HC) amino acid sequence of SEQ ID NO: 334;
the light chain (LC) amino acid sequence of SEQ ID NO: 331, and the heavy chain (HC) amino acid sequence of SEQ ID NO: 335;
the light chain (LC) amino acid sequence of SEQ ID NO: 331, and the heavy chain (HC) amino acid sequence of SEQ ID NO: 336;
the light chain (LC) amino acid sequence of SEQ ID NO: 331, and the heavy chain (HC) amino acid sequence of SEQ ID NO: 333; or the light chain (LC) amino acid sequence of SEQ ID NO: 331, and the heavy chain (HC) amino acid sequence of SEQ ID NO: 334.

7\. (Original) The method of claim 1, wherein an IL-1 stimulated signal, an IL-33 stimulated signal, or an IL-36 stimulated signal in the subject is decreased by at least 90%.

8\. (Original) The method of claim 1, wherein an intracellular signal initiated by one or more of IL-1a, IL-1p, IL-33, IL-36a, IL-36p, and IL-36y agonist binding to its cognate receptor in the subject is decreased by at least 90%.

9\. (Original) The method of claim 1, wherein the antibody specifically binds to one or more amino acid residues within domain 3 of human IL1 RAP, wherein domain 3 comprises positions 238 - 367 of the amino acid sequence of SEQ ID NO: 1 or 3.

10\. (Original) The method of claim 1, wherein the antibody does not bind to amino acid residues within domain 1 or domain 2 of human IL1 RAP; optionally, wherein domain 1 and domain 2 comprise positions 21 - 237 of the amino acid sequence of SEQ ID NO: 1 or 3.

11\. (Original) The method of claim 1, The antibody of claim 1, wherein the antibody cross- reacts with a cynomolgus monkey IL1 RAP polypeptide of SEQ ID NO: 8.

12\. (Original) The method of claim 1, wherein the antibody is a full-length antibody of class IgG; optionally, wherein the class IgG antibody has an isotype selected from IgG1, IgG2, IgG3, and IgG4.

13\. (Original) The method of claim 1, wherein the antibody is an Fc region variant; optionally wherein the Fc region variant alters effector function or alters half-life.

14\. (Original) The method of claim 13, wherein the Fc region variant comprises a set of YTE mutations.

15\. (Original) The method of claim 13, wherein the Fc region variant decreases effector function.

16\. (Original) The method of claim 1, wherein the antibody is formulated in a pharmaceutical composition comprising the antibody and a pharmaceutically acceptable carrier.

17\. (Canceled)

18\. (Canceled)

Appl. Ser. No. 17/486,864 19. (Original) The method of claim 1, wherein the antibody is administered systemically.

20\. (Original) The method of claim 1, wherein the antibody is administered at a dose of from about 1 pg/kg to about 15 mg/kg.

21\. (Original) The method of claim 1, wherein the method further comprises administering to the subject a dose of up to about 100 mg/kg.

OFFICE ACTION:
EXAMINER'S AMENDMENT
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 .
An examiner’s amendment to the record appears below. Should the changes and/or additions be unacceptable to applicant, an amendment may be filed as provided by 37 CFR 1.312. To ensure consideration of such an amendment, it MUST be submitted no later than the payment of the issue fee.
The application has been amended as follows:
In the title, please replace the current title with the following title:
-- Method of treating asthma with anti-IL1RAP antibodies --.
The allowed claims are: 1-16 and 19-21.
Reasons for Allowance
The following is an examiner’s statement of reasons for allowance: Applicant amended the claims and thus remove the reasons for the rejection.
Any comments considered necessary by applicant must be submitted no later than the payment of the issue fee and, to avoid processing delays, should preferably accompany the issue fee.  Such submissions should be clearly labeled “Comments on Statement of Reasons for Allowance.”

APPLICANT REBUTTAL: REMARKS
Status of the Claims
With entry of the above-listed amendments:
Claims 17-18 are Canceled.
Claim 1 is Currently Amended.
Claims 1-16 and 19-21 are Pending.
Amendments
In the Claims
Claim 1 has been amended as shown in the above listing to limit the IL1-mediated
disease to asthma. Support for this amendment is found in original claim 17 and throughout the specification.
No new matter is added by the amendments.
Applicant Comments
/Arg
uments Regarding Pendin
g
Ob
j
ections
/Rej
ections
Claim Rejections - 35 USC § 112
Claims 1-21 are rejected under 35 USC § 112 for allegedly failing to comply with the
written description requirement. In order to expedite prosecution and without acknowledging the propriety of the rejection, Applicant has amended the base independent claim to limit the recited IL1 RAP mediated disease to asthma as suggested by the Examiner. In view of this amendment, Applicant respectfully requests that the rejection for lack of written description under 35 USC § 112 be withdrawn.
Claims 1-21 are also rejected under 35 USC § 112 for allegedly failing to comply with the enablement requirement. In order to expedite prosecution and without acknowledging the propriety of the rejection, Applicant has amended the base independent claim to limit the recited IL1 RAP mediated disease to asthma as suggested by the Examiner. In view of this amendment, Applicant respectfully requests that the rejection for lack of enablement under 35 USC § 112 be withdrawn.
Conclusions