DETAILED ACTION
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 .
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 2/13/2026 has been entered.
Amended claims 60, (2/13/2026), previously presented claims 71, 89,and new claim 90, (2/13/2026), are under consideration by the Examiner.
Claims 45-47, 49, 53, 56-57, and 59 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention.
Claims 1-44, 48, 50-52, 54-55, 58, 61-68, 70, and 72-88,have been canceled.
3. Receipt of Applicant's arguments and amendments filed on 2/13/2026 is acknowledged.
4. Applicant's arguments filed on 2/13/2026 have been fully considered and were non-persuasive. The remaining issue is stated below.
Claim rejections-35 U.S.C. 102
5. 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.
5a. Claims 60, 71, 89-90 are rejected under 35 U.S.C. 102(a) (1) as being anticipated by WO 2016/156440 A1.
WO 2016/156440 A1 teaches a method of administering an IL-33 antagonist, specifically the "33_640087-7B" antibody having SEQ ID NO:1 and 19 of the present application, to treat a number of inflammatory diseases such as asthma or COPD (See paragraph [567], [450], [451], [667] and [668)]). The IL-33 antibody disclosed in the reference comprises the VH domain of amino acid sequence set forth in SEQ ID NO:522 (126 amino acids) which is 100% identical to the VH domain of SEQ ID NO:1 (comprising a VHCDR1 having the sequence of SEQ ID NO: 37, a VHCDR2 having the sequence of SEQ ID NO: 38, and a VHCDR3 having the sequence of SEQ ID NO: 39) in the instant application (See SEQUENCE COMPARISON “B” below), and the VL domain of amino acid sequence SEQ ID NO:618 (106 amino acids) in the reference is 100% identical to the VL domain of SEQ ID NO:19 (comprising a VLCDR1 having the sequence of SEQ ID NO: 40, a VLCDR2 having the sequence of SEQ ID NO: 41, and a VLCDR3 having the sequence of SEQ ID NO: 42) in the instant application (See SEQUENCE COMPARISON “A” below). The reference also teaches that "the oxidized form of IL-33 (IL-33 DSB) binds to its receptor for advanced glycation end products (RAGE) and signals through this alternative pathway" (See paragraph [10]). The limitations recited in claim 71 (improves mucus clearance, inhibits or reduces abnormal mucus production, inhibits an abnormal mucus composition, inhibits abnormal epithelium remodeling, inhibits or reduces abnormal goblet cell differentiation or proliferation, and/or reduces the thickness of the respiratory epithelium, wherein the abnormal mucus composition comprises an increase in MUCSAC:MUCSB ratio, an increase in MUCSAC contained in mucus, or an increase in thickness of mucus), are limitations inherent to the method disclosed in the reference. Therefore, the reference anticipates claims 60, 69, 71, and 89-90.
SEQUENCE COMPARISON “A”
RESULT 1
BDG19045
ID BDG19045 standard; protein; 106 AA.
XX
AC BDG19045;
XX
DT 17-NOV-2016 (first entry)
XX
DE Human anti-IL-33 antibody 33_640087-7B VL, SEQ ID:618.
XX
KW IL-1F11 protein; IL33 protein; Interleukin 33 ligand; allergy; antibody;
KW antibody production; antibody therapy; antiinflammatory; asthma;
KW chronic obstructive pulmonary disease; expression; inflammatory disease;
KW light chain variable region; protein detection; protein therapy;
KW therapeutic.
XX
OS Homo sapiens.
XX
CC PN WO2016156440-A1.
XX
CC PD 06-OCT-2016.
XX
CC PF 30-MAR-2016; 2016WO-EP056973.
XX
PR 31-MAR-2015; 2015US-0140913P.
XX
CC PA (ASTR ) MEDIMMUNE LTD.
XX
CC PI Cohen ES, Lowe DC, Butler R, Scott IC, Vousden KA, Strain MD;
CC PI Carmen S, England EH, Kemp BP, Rees DG, Overed-Sayer CL;
CC PI Mustelin TM, Sleeman M, Houslay K;
XX
DR WPI; 2016-62584P/72.
DR N-PSDB; BDG19044.
XX
XX
SQ Sequence 106 AA;
Query Match 100.0%; Score 558; Length 106;
Best Local Similarity 100.0%;
Matches 106; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1 SYVLTQPPSVSVSPGQTASITCSGEGMGDKYAAWYQQKPGQSPVLVIYRDTKRPSGIPER 60
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1 SYVLTQPPSVSVSPGQTASITCSGEGMGDKYAAWYQQKPGQSPVLVIYRDTKRPSGIPER 60
Qy 61 FSGSNSGNTATLTISGTQAMDEADYYCGVIQDNTGVFGGGTKLTVL 106
||||||||||||||||||||||||||||||||||||||||||||||
Db 61 FSGSNSGNTATLTISGTQAMDEADYYCGVIQDNTGVFGGGTKLTVL 106
SEQUENCE COMPARISON “B”
RESULT 1
BDG18949
ID BDG18949 standard; protein; 126 AA.
XX
AC BDG18949;
XX
DT 17-NOV-2016 (first entry)
XX
DE Human anti-IL-33 antibody 33_640082-7 VH, SEQ ID:522.
XX
KW IL-1F11 protein; IL33 protein; Interleukin 33 ligand; allergy; antibody;
KW antibody production; antibody therapy; antiinflammatory; asthma;
KW chronic obstructive pulmonary disease; expression;
KW heavy chain variable region; inflammatory disease; protein detection;
KW protein therapy; therapeutic.
XX
OS Homo sapiens.
XX
CC PN WO2016156440-A1.
XX
CC PD 06-OCT-2016.
XX
CC PF 30-MAR-2016; 2016WO-EP056973.
XX
PR 31-MAR-2015; 2015US-0140913P.
XX
CC PA (ASTR ) MEDIMMUNE LTD.
XX
CC PI Cohen ES, Lowe DC, Butler R, Scott IC, Vousden KA, Strain MD;
CC PI Carmen S, England EH, Kemp BP, Rees DG, Overed-Sayer CL;
CC PI Mustelin TM, Sleeman M, Houslay K;
XX
DR WPI; 2016-62584P/72.
DR N-PSDB; BDG18948.
XX
CC PT New isolated interleukin 33 used in pharmaceutical composition for
CC PT treating patient with inflammatory condition e.g. allergic disorder,
CC PT asthma or chronic obstructive pulmonary disease.
XX
CC PS Example 8; SEQ ID NO 522; 309pp; English.
XX
XX
SQ Sequence 126 AA;
Query Match 100.0%; Score 665; Length 126;
Best Local Similarity 100.0%;
Matches 126; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1 EVQLLESGGGLVQPGGSLRLSCAASGFTFSSYAMSWVRQAPGKGLEWVSGISAIDQSTYY 60
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1 EVQLLESGGGLVQPGGSLRLSCAASGFTFSSYAMSWVRQAPGKGLEWVSGISAIDQSTYY 60
Qy 61 ADSVKGRFTISRDNSKNTLYLQMNSLRAEDTAVYYCARQKFMQLWGGGLRYPFGYWGQGT 120
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 61 ADSVKGRFTISRDNSKNTLYLQMNSLRAEDTAVYYCARQKFMQLWGGGLRYPFGYWGQGT 120
Qy 121 MVTVSS 126
||||||
Db 121 MVTVSS 126
Applicant argues that the features “inhibit an Epidermal Growth Factor Receptor (EGFR)-mediated effect, wherein the respiratory disease is characterised by aberrant EGFR activity" lies in identification of a new patient group for treatment with an anti-IL-33 antagonist, the inventors of instant application were the first to identify EGFR signaling as involved in IL-33 mediated respiratory diseases, and the discovery of the involvement of an entirely different signaling pathway is a new technical effect of the anti-IL-33 antibody which opens up the possibility of different treatment opportunities, which creates a distinct clinical scenario and patient subpopulation. Furthermore, Applicant argues that WO 2016/156440 Al teaches administering IL-33 antagonists, including 33640087 7B antibody, for general inflammatory indications such as asthma and COPD, but is silent on EGFR, EGFR-driven pathophysiology, and EGFR-mediated effects, WO 2016/156440 Al does not instruct the skilled artisan to select, diagnose, or treat the subset of respiratory-disease patients whose disease is characterized by aberrant EGFR activity, nor does it recognize a therapeutic purpose of inhibiting EGFR-mediated effects, the cited Anagnostis et al. (2012) study demonstrates that aberrant EGFR activity is present only in a subset of COPD patients (moderate-COPD) and is absent in other COPD patients, and therefore, administering an IL-33 antagonist to "COPD" as taught in WO 2016/156440 Al does not necessarily involve a patient whose disease is characterized by aberrant EGFR activity, nor does it necessarily inhibit an EGFR-mediated effect. Additionally, Applicant argues that the same reasoning applies to asthma, WO 2016/156440 Al's generic asthma teaching does not necessarily result in the treatment of respiratory disease characterized by aberrant EGFR activity, nor inhibition of EGFR mediated effects, and is silent on bronchitis, bronchiectasis, and asthma-COPD overlap (ACO). However, contrary to Applicant’s arguments, in the method recited in the reference, the identical IL-33 antibody is administered to the same group of COPD or asthma patients, for the treatment of asthma or COPD, and the inhibition of EGFR would naturally and necessarily flow from the teachings of the prior art method. The limitations recited in claim 60 (aberrant EGFR activity), and 71 (the method improves mucus clearance, inhibits or reduces abnormal mucus production, inhibits an abnormal mucus composition, inhibits abnormal epithelium remodeling, inhibits or reduces abnormal goblet cell differentiation or proliferation, and/or reduces the thickness of the respiratory epithelium, wherein the abnormal mucus composition comprises an increase in MUCSAC:MUCSB ratio, an increase in MUCSAC contained in mucus, or an increase in thickness of mucus), are inherent to the method disclosed in the reference. Furthermore, claim 60 recites “wherein the respiratory disease is…COPD, ….asthma….” which encompasses all COPD patients including those with moderate-COPD. Therefore, the reference anticipates claims 60, 71, and 89-90.
Conclusion
No claim is allowed.
Claims 60, 71, 89, and 90 are rejected.
All claims are identical to or patentably indistinct from, or have unity of invention with claims in the application prior to the entry of the submission under 37 CFR 1.114 (that is, restriction (including a lack of unity of invention) would not be proper) and all claims could have been finally rejected on the grounds and art of record in the next Office action if they had been entered in the application prior to entry under 37 CFR 1.114. Accordingly, THIS ACTION IS MADE FINAL even though it is a first action after the filing of a request for continued examination and the submission under 37 CFR 1.114. See MPEP § 706.07(b). 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.
Advisory Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PREMA MARIA MERTZ whose telephone number is (571)272-0876. The examiner can normally be reached on Monday to Thursday from 7:30am to 6:00pm.
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/PREMA M MERTZ/ Primary Examiner, Art Unit 1674