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 .
Claims Status
The remarks filed 03/02/2026 are acknowledged.
Claims 1-16 are pending.
Applicant’s election of Group I, claims 1-4 and 14-16, in the reply filed on 03/02/2026 is acknowledged. Applicant’s election of the following species in the reply filed 03/02/2026 is acknowledged: the VH of SEQ ID NO: 4, the VL of SEQ ID NO: 18, scFv fragment for the antibody format, and SEQ ID NO: 38 for the sequence of the scFv. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)). Upon further consideration, the election of species requirement for Species Group D, the sequence of the scFv, is withdrawn.
Claims 5-13 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention and/or species there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 03/02/2026.
Therefore, claims 1-4 and 14-16 are under examination.
Priority
The instant application is a 371 of PCT/EP2021/087576 and claims priority to European applications EP20216938.9, EP20216957.9, and EP20216928.0. Receipt is acknowledged of all certified copies of papers required by 37 CFR 1.55. Priority is given with the earliest effective filing date of 12/23/2020.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 03/02/2026 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Objections
Claims 1 and 3 are objected to because of the following informalities: Claim 1 recites “IL-4R”, “VH”, and “VL”, and claim 3 recites “FAB”, “Fv”, “scFv”, and “dsFv”.
The first time an acronym is used, it must be accompanied by the definition of the abbreviation. Appropriate correction is required.
Claim 4 is objected to as being dependent upon a rejected base claim (i.e. claim 1), but would be allowable if rewritten in independent form including all of the limitation of the base claim and any intervening claim.
Claim 16 is objected to because of the following informalities: Claim 16 includes the limitation “particularly.” MPEP 2173.05(d) states, “Description of examples or preferences is properly set forth in the specification rather than the claims. If stated in the claims, examples and preferences may lead to confusion over the intended scope of a claim.” The “particularly” should be removed entirely. Appropriate correction is required.
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 15 and 16 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.
Claim 15 recites the limitation “the antibody variable domain of claim 1 for use as a medicament” and claim 16 recites the limitation “the antibody variable domain of claim 1 for use in the treatment of a disease”. The “for use in” indicates an intended use. However, it is unclear if this claim is a product claim or a method claim which makes it uncertain if infringement would occur if just the product of the antibody variable domain exists or if infringement would occur only when the antibody variable domain is used as a medicament or in the treatment of a disease. Therefore, these claims are indefinite.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-3 and 14-16 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 4, 7, 10, and 17-18 of copending Application No. 18/258,858 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other.
Regarding claims 1 and 2 (option c) of the instant application, claim 1 of the reference application teaches a multispecific antibody comprising: a) one or two binding domains, which specifically bind to IL-4R (IL4R-BD), and b) one or two binding domains, which specifically bind to IL-31 (IL31-BD) and claim 10 of the reference application teaches wherein said IL4R-BDs comprise b) a heavy chain variable domain comprising an amino acid sequence of SEQ ID NO: 4 and a light chain variable domain comprising an amino acid sequence of SEQ ID NO: 11.
SEQ ID NOs: 4 and 11 have 100% sequence identity to SEQ ID NOs: 4 and 18 of the instant claim, respectively.
Regarding claim 3 of the instant application, claim 4 of the reference application teaches the multispecific antibody of claim 1, wherein the format of said multispecific antibody is a Morrison format and claim 7 teaches the multispecific antibody of claim 4, wherein the format of the multispecific antibody is selected from a Morrison-L (IgG Cl-scFv fusion) and a Morrison-H (IgG CH3-scFv fusion) format.
Regarding claim 14 of the instant application, claim 17 of the reference application teaches a pharmaceutical composition comprising the multispecific antibody of claim 1 and a pharmaceutically acceptable carrier.
Regarding claims 15 and 16 of the instant application, claim 18 of the reference application teaches a method of treating a condition comprising the administration of the multispecific antibody of claim 1 to a subject in need thereof (medicament), wherein the condition is selected from the group consisting of pruritus-causing allergic diseases, pruritus-causing inflammatory diseases, pruritus-causing autoimmune diseases, atopic dermatitis, acute allergic contact dermatitis, chronic spontaneous urticaria, bullous pemphigoid, alopecia areata, dermatomyositis, prurigo nodularis, psoriasis, or atopic asthma.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-3 and 14 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 8, 13-14, and 19 of copending Application No. 18/863,208 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other.
Regarding claims 1, 2, and 3 of the instant application, claim 8 teaches an antibody variable domain, which binds to a target antigen, comprising: (i) a variable heavy chain (VH) and (ii) a variable light chain (VL), claim 13 of the reference application teaches an antibody comprising one or more antibody variable domains as defined in claim 8, wherein said one or more antibody variable domains are, independently of each other, selected from an Fv, a disulfide stabilized Fv, an scFv and a disulfide stabilized scFv, and claim 14 teaches the antibody of claim 13, wherein said antibody is a heterodimer consisting of two chains having a pair of sequences selected from the following SEQ ID NOs: 418 and 419.
SEQ ID NOs: 418 and 419 of the reference application comprise sequences with 100% sequence identity to SEQ ID NOs: 18 and 4 of instant claims 1 and 2. Since the sequences comprised in SEQ ID NOs: 418 and 419 of the reference application are 100% identical to the claimed sequences that bind to IL-4R, then SEQ ID NOs: 418 and 419 must bind IL-4R since function flows from structure. See MPEP 2112.01(II).
Regarding claim 14 of the instant application, claim 19 of the reference application teaches a pharmaceutical composition comprising the antibody variable domain of claim 8 and a pharmaceutically acceptable carrier.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-3 and 14-16 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 8, 13-14, and 19 of copending Application No. 18/863,208 (reference application), as applied to claims 1-3 and 14 above, in view of Egholm et al., 2019 (instant PTO-892).
The teachings of the reference application are above.
However, the reference application does not specifically teach that the antibody variable domain for use as a medicament or for use in the treatment of a disease, particularly an inflammatory disease.
Egholm teaches dupilumab, a monoclonal antibody blocking IL-4Rα, has been shown to be effective as a treatment of moderate-to-severe atopic dermatitis (AD; inflammatory disease) [page 7, left column, third paragraph].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have used the antibody variable domain that binds to IL-4R of the reference application for use as a medicament and in the treatment of an inflammatory disease. One would have been motivated to have used the antibody variable domain of the reference application for use as a medicament and in the treatment of an inflammatory disease with a reasonable expectation of success because Egholm teaches dupilumab, a monoclonal antibody blocking IL-4Rα, has been shown to be effective as a treatment of moderate-to-severe atopic dermatitis (AD; inflammatory disease).
This is a provisional nonstatutory double patenting rejection.
Allowable Subject Matter
The Examiner searched SEQ ID NOs: 33 to 39 as recited in instant claim 4, which were free of the art. As such, the election of species requirement for Species Group D, set forth in the reply filed 03/02/2026, is withdrawn as stated above.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Brittney E Donoghue whose telephone number is (571)272-9883. The examiner can normally be reached Mon - Fri 7:30 - 3:30.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jeffrey Stucker can be reached at (571) 272-0911. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/B.E.D./Examiner, Art Unit 1675
/JEFFREY STUCKER/Supervisory Patent Examiner, Art Unit 1675
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