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 .
Election/Restrictions
Applicant’s election without traverse of Group I in the reply filed on 03/19/2026 is acknowledged. Applicant has further elected “inflammatory disease” as the species of diseases.
Further, Applicant’s response and clarifications (05/11/2026) to the letter of 04/20/2026 is appreciated. The elected inventive antibody comprises the VL region of SEQ ID NO:36 and the VH region of SEQ ID NO:86. The CDRs for the light region comprise SEQ IDs 117, 136, and 5, and the CDRs for the heavy region comprise SEQ IDs 8, 149, and 10.
Claims 49-87 are pending.
Claims 50, 52-57, 59-63, 65-71, 77-83, and 85-86 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 03/19/2026.
Claims 49, 51, 58, 64, 72-76, 84, and 87 are pending and are currently under consideration.
Specification
The disclosure is objected to because of the following informalities: The brief description of the drawings (in particular, Figure 5) has several references to colored items. For example, the specification teaches [0267] The IL-1 RAcP is shown in pale blue with semi-transparent surface. The #A2 Fab is shown as ribbons. IL-1RI is colored in red and IL-1β in green. D. The IL-1RAcP-side of the IL-1RAcP-IL-1RI interface is shown in orange.
Thus, it appears that some of applicants’ drawings may need to be submitted in color to distinguish these details. Any structural detail that is essential for a proper understanding of the disclosed invention should be shown in the drawing. MPEP § 608.02(d). Applicants are reminded that color photographs and color drawings are not accepted in utility applications unless a petition filed under 37 CFR 1.84(a)(2) is granted. Any such petition must be accompanied by the appropriate fee set forth in 37 CFR 1.17(h), one set of color drawings or color photographs, as appropriate, if submitted via the USPTO patent electronic filing system or three sets of color drawings or color photographs, as appropriate, if not submitted via the via USPTO patent electronic filing system, and, unless already present, an amendment to include the following language as the first paragraph of the brief description of the drawings section of the specification: Color photographs will be accepted if the conditions for accepting color drawings and black and white photographs have been satisfied. See 37 CFR 1.84(b)(2).
Claim Objections
Claim 49 is objected to for recitation of non-elected antibodies in items (i) and items (iii) through (vii).
Claim 51 is objected to for recitation of non-elected antibodies in items (ii) through (iv).
Claim 64 is objected to for recitation of non-elected antibodies in items (i) and items (iii) through (vii).
Claim 87 is objected to for reciting, “blocks the binding of an anti-IL1RAP according to claim 49” as grammatically unclear. The claims will be interpreted as blocks the binding of an anti-IL1RAP antibody.
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.
Claims 49, 64, 72-76, 84 and 87 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 49, 64, 72-76, 84 and 87 are indefinite for requiring CDR sequences (L-CDR1, L-CDR2, L-CDR3 and H-CDR1, H-CDR2, H-CDR3) without specifying the particular sequences associated with each CDR or the method by which they are meant to be determined (e.g. Chothia, Kabat, IGMT, etc.). The recited SEQ ID NOs in the claims correspond to variable heavy and light chain sequences, and it is unclear which subsequences thereof are intended to correspond to which CDR. Further, even when relying upon [0281] the Kabat, Chothia and IMGT numbering schemes, there are differences and drawbacks. In some cases, some of the CDRs identified by the four methods are almost identical (e.g. L3, H3), while in other CDRs (e.g. L2, H1, and H2) there are substantial differences between the methods. Thus, there is substantial indefiniteness when claims refer to complementary determining regions without first defining which amino acids they intend to cover.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 87 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Agerstam et al. (US Patent 9,796,783, published October 2017).
Claim 87 is drawn to any antibody or antigen-binding fragment which binds to the D3-domain of IL-1RAcP (SEQ ID NO:187) wherein such antibody or antigen-binding fragment “blocks the binding” of an anti-IL1RAP antibody according to claim 49 to IL1RAP by at least 80%.
Fact 1: IL-1RAcP is the same protein as IL1RAP.
Fact 2: The only antibody of claim 49 that was “searched and examined” was the elected antibody comprising the light chain variable region of SEQ ID NO:36 and the heavy chain variable region of SEQ ID NO:86.
Agerstam et al. teach (column 3, lines 15-30) antibodies or antigen binding fragments thereof with binding specificity for IL1RAP. The reference further teaches [column 42] that “a majority of anti-IL1RAP antibodies tested for target validation bind to “domain 3” or “D3”. Table 4 (reproduced below) shows that 4 clones (CAN03, CAN07, CAN08, CAN01) and KMT-1 (polyclonal) through epitope mapping revealed specific binding of anti-IL1RAP antibodies to Domain 3. Thus, it would be expected, that at least one of these anti-IL1RAP antibodies would compete or block the binding of an anti-IL1RAP antibody comprising the light chain variable region of SEQ ID NO:36 and the heavy chain variable region of SEQ ID NO:86 to domain 3 of IL1RAcP as all recognize epitopes within the same D3 domain.
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Conclusion
Claim 58 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to GARY B NICKOL, Ph.D. whose telephone number is (571)272-0835. The examiner can normally be reached M-F 9AM-5:30PM.
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, Julie Wu 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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/GARY B NICKOL/Primary Examiner, Art Unit 1643
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