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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 5/22/2026 has been entered.
Amended claim 60, (5/22/2026), and previously presented claims 71, 89, are under consideration by the Examiner.
Claims 1-59, 61-70, 72-88, and 90 have been canceled.
Receipt of Applicant's arguments and amendments filed on 5/22/2026 is acknowledged.
The following previous rejections and objections are withdrawn in light of applicants amendments filed on 5/22/2026:
(i) the rejection of claims 60, 71, 89-90 under 35 U.S.C. 102(a)(1) as being anticipated by WO 2016/156440 A1.
Applicant's arguments filed on 5/22/2026 have been fully considered and were persuasive. The new issue is stated below.
Claim rejections-35 USC § 112(b)
7. 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.
7a. Claims 60, 71, and 89 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 pre-AIA the applicant regards as the invention.
Claim 60, line 8, is vague and indefinite because it recites “a binding molecule”, while the only “binding molecule” disclosed in the specification is “an antibody”. Amendment of the claim to delete the recitation of “a binding molecule”, and recitation of “an antibody” is required to obviate this rejection.
Claims 71 and 89 are vague and indefinite insofar as they depend on the above rejected claim 60 for their limitations.
Claim rejections-35 U.S.C. 103
8. In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negatived by the manner in which the invention was made.
This application currently names joint inventors. In considering patentability of the claims under pre-AIA 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of pre-AIA 35 U.S.C. 103(c) and potential pre-AIA 35 U.S.C. 102(e), (f) or (g) prior art under pre-AIA 35 U.S.C. 103(a).
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under pre-AIA 35 U.S.C. 103(a) are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
8a. Claims 60, 71, and 89 are rejected under 35 U.S.C. 103 as being unpatentable over WO 2016/156440 A1.
WO 2016/156440 A1 teaches a method of administering an IL-33 antagonist, specifically the "33_640087-7B" antibody having a VH domain of the amino acid sequence of SEQ ID NO:1 and a VL domain of the amino acid sequence of SEQ ID NO:19 which are identical to the VH and VL domains 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 because the identical antibody is administered for treating COPD. The prior art is silent with respect to a method of treating bronchitic chronic obstructive pulmonary disease (COPD) in a human subject in need thereof, comprising administering to the human subject a therapeutically effective amount of the claimed antibody as an IL- 33 antagonist to inhibit an Epidermal Growth Factor Receptor (EGFR)-mediated effect.
It would have been obvious to one of ordinary skill in the art, at the time the instant invention was conceived, to modify the method of WO 2016/156440 A1 and administer the IL-33 antibody of WO 2016/156440 A1 to a subject with bronchitic COPD which is a species of the generic COPD condition. The WO 2016/156440 A1 reference teaches administering, with success, the claimed IL-33 antibody for treatment of COPD in a human subject. Since treatment with the claimed IL-33 antibody for COPD in a subject was successful at the time of the instant invention, one of skill in the art would be motivated to explore other species of COPD for treatment of COPD with the same IL-33 antibody with an expectation of success, to improve treatment outcomes for bronchitic COPD. Therefore, healthcare providers can continue to provide patients with bronchitic COPD with effective treatments, based on the teachings in the reference. Here, the recited functional characterization outcomes in the claimed method would naturally and necessarily flow from the method disclosed in the prior art. Accordingly, the prior art teaches the same method claimed, and the treatment product used in the prior art method is the same as the claimed method. Therefore, the claimed functional outcome would naturally and necessarily flow from the method of treatment disclosed in the prior art.
Since the office does not have a laboratory to test the reference materials, it is Applicant’s burden to show that the reference material does not have the properties recited in the instant claims. See In re Best, 195 USPQ 430, 433 (CCPA 1977); In re Marosi, 218 USPQ 289, 292-293 (Fed. Cir. 1983); and In re Fitzgerald et al., 205 USPQ 594 (CCPA 1980).
Furthermore, it would have been obvious to one of ordinary skill in the art, in this case, a pulmonologist, to have the motivation to treat a patient with bronchitic COPD and target a species of COPD, bronchitic COPD, because an efficacious course of treatment was obtained by administering the claimed IL-33 antibody to treat the genus COPD which is an umbrella term that includes chronic bronchitis and emphysema, both of which contribute to reduced lung function over time.
Therefore, the teachings of the reference renders obvious claims 60, 71, and 89 in the absence of evidence to the contrary.
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 amended claim 60 is directed to a method of treating bronchitic COPD, wherein bronchitic COPD is a specific form of COPD in which chronic bronchitis is present, and "bronchitic COPD patients have higher total mucin concentrations and mucous hypersecretion” (See specification, page 29, lines 15-19), and "bronchitic COPD patients may particularlv benefit from treatment with an IL-33 antagonist ... by the discovery that IL-33 antagonists inhibit EGFR activity and improve mucociliary physiology (See specification, page 29, lines 15-19). Furthermore, Applicant argues that the application as filed explains that "the present application shows for the first time that the use of an IL-33 antagonist can ... decrease mucus production, and improve mucociliary movement in patients with abnormal epithelium physiology ... via direct inhibition of RAGE/EGFR-mediated oxIL-33 activity" (See specification, page 2, lines 23-29). In addition, Applicant argues that Cohen does not discuss treatment of bronchitic COPD-the specific subset of COPD, wherein chronic bronchitis is present and the Office has not established that chronic bronchitis is necessarily present in COPD patients generally, rather, the application as filed explains that bronchitic COPD is distinct from COPD, as discussed above. However, contrary to Applicant’s arguments, the patient group with bronchitic COPD, is a species of patients with COPD, and one of skill in the art would be motivated, with an expectation of success, to administer to patients with bronchitic COPD, the identical IL-33 antibody administered to patients with COPD, to target IL-33 in patients with bronchitic COPD, and the inhibition of EGFR would naturally and necessarily flow from the teachings of the prior art method. The limitations recited in claim 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), would be inherent to the method disclosed in the reference because the identical antibody is administered to the same species of patients. Therefore, the reference renders obvious claims 60, 71, and 89 in the absence of evidence to the contrary.
Conclusion
No claim is allowable.
Claims 60, 71, and 89 are rejected.
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 1646
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