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 1-3,5-10, 16-18, 20-22, 24, 26, 27, 32, 34, 36, 43-48, 53, 56-58, 67, 68, 70, 73, 83, 87, 90-92 are pending and examined on merits.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 06/30/2025 and 10/24/2025 was considered by the examiner.
Priority
Acknowledgment is made of applicant’s claim for foreign priority under 35 U.S.C. 119 (a)-(d) to EP20212128.1 filed 12/07/2020. The US effective filing date is 12/06/2021, the filing date of PCT/EP2021/084402.
Specification Nucleotide and/or Amino Acid Sequence Disclosures
The disclosure is objected to because of the following:
Specific deficiency – Nucleotide and/or amino acid sequences appearing in the drawings (e.g., figures 2-8) are not identified by sequence identifiers in accordance with 37 CFR 1.821(d). Sequence identifiers for nucleotide and/or amino acid sequences must appear either in the drawings or in the Brief Description of the Drawings.
Required response – Applicant must provide:
Replacement and annotated drawings in accordance with 37 CFR 1.121(d) inserting the required sequence identifiers;
AND/OR
A substitute specification in compliance with 37 CFR 1.52, 1.121(b)(3) and 1.125 inserting the required sequence identifiers into the Brief Description of the Drawings, consisting of:
A copy of the previously-submitted specification, with deletions shown with strikethrough or brackets and insertions shown with underlining (marked-up version);
A copy of the amended specification without markings (clean version); and
A statement that the substitute specification contains no new matter.
Appropriate correction is required.
The incorporation by reference paragraph required by 37 CFR 1.834(c)(1), 1.835(a)(2), or 1.835(b)(2) is missing, defective or incomplete. The incorporation by reference paragraph in the specification filed 06/05/2023 recites the incorrect file name, creation date, and file size. The incorporation by reference paragraph should recite: “The instant application contains a Sequence Listing which has been submitted electronically in ASCII format and is hereby incorporated by reference in its entirety. Said ASCII copy, created on dates, is named file name and is XXX bytes in size.”
Required response - Applicant must:
• Provide a substitute specification in compliance with 37 CFR 1.52, 1.121(b)(3), and 1.125 inserting the required incorporation by reference paragraph, consisting of:
• A copy of the previously-submitted specification, with deletions shown with strikethrough or brackets and insertions shown with underlining (marked-up version);
• A copy of the amended specification without markings (clean version); and
• A statement that the substitute specification contains no new matter.
Claim Rejections - 35 USC § 112
Claims 1-3,5-10, 16-18, 47, 53, 56-58, 83, 87, and 90-92 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for those antibodies claimed by minimum six CDRs (three from VH and three from VL) does not reasonably provide enablement for antibodies claimed by their target structure The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make the invention commensurate in scope with these claims.
Factors to be considered in determining whether undue experimentation is required to practice the claimed invention are summarized In re Wands (858 F2d 731, 737, 8 USPQ2d 1400, 1404 (Fed.Cir.1988)). The factors most relevant to this rejection are the scope of the claim, the amount of direction or guidance provided, the lack of sufficient working examples, the unpredictability in the art and the amount of experimentation required to enable one of the skilled in the art to practice the claimed invention.
The scope of the claim
Claims 1-3,5-10, 16-18, 47, 53, 56-58, 83, 87, 90-92 are drawn to a genus of multispecific antibodies binding to IL-13 and IL-22. An antibody format claim had been allowed if said antibody format is an invention. However, the claimed invention is not a new format. An antibody no longer can be claimed by reciting a new target structure in this case, IL-13 and IL-22 according to the Supreme Court Amgen Inc v. Sanofi (5/18/23). The scope potentially encompasses “quintillion” unique species as discussed in Amgen v. Sanofi, 598 U.S. 594 (2023). Briney et al. (Nature 2019. 566:393-399) was cited in the Supreme Court decision to determine a potential scope of the asserted antibody claims. The instant antibody claims are similar to those asserted Amgen claims in that both claims recite epitope structures.
As for claim 17, drawn to an antibody format having at least three antibodies (IL-13, IL-22 and serum albumin), the format is not new since the format is taught by US PAT 10457748, therefore Capon v. Eshar, 418 F.3d 1349, 1357, 76 USPQ2d 1078, 1084 (Fed. Cir. 2005) does not apply. Note further detail about the antibody format taught by US PAT 10457748 under 103 rejection.
Claims 20-22 recite structures but not the three-6CDR sets for three target bindings. , Claim 24, 26, 27, 32 recite VL/VH pair for one target binding each. Claim 38 have same problem.
The amount of direction provided by the inventor and existence of working examples
The specification discloses IL-13 or IL-22 recited in claim 34. The specification also discloses anti-human serum albumin antibodies previously disclosed in other applicant applications.
The level of predictability in the art
Na et al of record (“Na”) NPL18, IDS filed 10/24/2025, E-publication date: May 15, 2020 reviews the state of art regarding atopic dermatitis (AD) immune pathophysiology including IL-13 and IL-22. Note Fig. 1. Na also teaches (Note Table II) IL-13 and IL-22 antibodies are known and used in clinal settings. They all have different structures although they are binding to IL-13 and IL-22. This indicates a target structure does not predict the binding molecule structures.
Additionally, in its recent decision in Baxalta Inc. v. Genentech, Inc., No. 2022-1461, 2023 WL 6135930 (Fed. Cir. Sept. 20, 2023) the Federal Circuit found the facts of this case to be "materially indistinguishable from those in Amgen." Baxalta, 2023 WL 6135930, at *4. According to the Federal Circuit, claim 1 covers "millions of potential candidate antibodies" (id.) that bind to Factor IX/IXa and increase the procoagulant activity of Factor IXa. The court, however, noted that the specification discloses the amino acid sequence of just 11 of those antibodies. And like the roadmap in the patents at issue in Amgen, "the '590 patent's roadmap simply directs skilled artisans to engage in the same iterative, trial-and-error process the inventors followed to discover the [11] antibodies they elected to disclose." (Id.) Missing from the specification, according to the Federal Circuit, was "'a quality common to every functional embodiment' ... that would allow a skilled artisan to predict which antibodies will perform the claimed functions" (id.; quoting Amgen Inc. v. Sanofi., 598 U.S. 594, 614 (2023)), such as a common structural or other feature that would allow the antibodies to perform the claimed functions, or an explanation as to why the 11 antibodies do so and others do not. (Baxalta, 2023 WL 6135930, at *4). And the Federal Circuit was not persuaded by Baxalta's argument that its disclosed hybridoma-and screening process "predictably and reliably generates new claimed antibodies every time it is performed" (id.), because "it is undisputed that to practice the full scope of the claimed invention, skilled artisans must make candidate antibodies and screen them to determine which ones perform the claimed functions." (Id.).
The Supreme Court (Amgen, 2023) held that the Amgen application was not enabled for the genus of antibodies that (1) bind to specific amino acid residues on PCSK9, and (2) block PCSK9 from binding to LDL receptors, even though Amgen disclosed numerous PCSK9 antibodies that met (1) and (2) requirements. Amgen’s arguments that scientists could make other antibodies that meet these two functions did not persuade the court. The case law applies to the instant claims which require a genus of multi-specific anti-IL-13 and IL-22 and/or anti-serum albumin.
The quantity of experimentation needed to make or use the invention based on the disclosure
Based on the content of the disclosure and the state of art, in view of the recent Supreme Court ruling regarding nature of an antibody invention, a skilled artisan, through extensive trial-and-error experimentation, would have to make antibodies, validate their functions. For all of these reasons, the specification does not enable one of ordinary skill in the art to make and/or use what is claimed except for the antibodies claimed by structures in the claims not rejected here.
Amending the base claim by incorporating the structures of anti-IL-13 or IL-22 antibodies recited in claims 20 and 21 would obviate this rejection.
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.
Claim 22 is 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 22 recites the limitation "the albumin-binding domain" in line 2. There is insufficient antecedent basis for this limitation in the claim. Amending claim 22 to depend from claim 16 would obviate this rejection.
Claim 38 recites the limitation "the albumin-binding domain" in line 2. There is insufficient antecedent basis for this limitation in the claim.
Priority
Acknowledgment is made of applicant’s claim for foreign priority under 35 U.S.C. 119 (a)-(d) to EP20212128.1 filed 12/07/2020. The US effective filing date is 12/06/2021, the filing date of PCT/EP2021/084402.
Claim Rejections - 35 USC § 103
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 (i.e., changing from AIA to pre-AIA ) 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 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) Claims 1-3,5-10, 16-18, 22, 44-48, 53, 56-58, 83, 87, 90-92 are is/are rejected under 35 U.S.C. 103 as being unpatentable over WO2010/035012 of record (“Adams”, FP11 of IDS filed 6/30/2025 in view of Na et al of record (“Na”) NPL18, IDS filed 10/24/2025, E-publication date: May 15, 2020.
The claimed invention is drawn to multi-specific antibody binding to both IL13 and IL22 and human serum albumin, a polynucleotide encoding the antibody, a vector having the nucleotide, a method of treating atopic dermatitis and other disease recited in claim, for example, claim 87.
Adams teaches multi-specific format antibodies. Note Figure 2, a schematic description of disclosed one of them is a Fab’ fragment with single domains (dab) linked to VH and VL of the Fab’ fragment and also teaches that dab is an anti-human serum albumin attached. Note Figure 2. The antibody format shown at Figure 2A is same as the format shown in instant claim 17. At page 13, line 26-27 Fab’ fragments each are fused at their C-terminus via linker to dabs. One of dabs binds to human albumin (note page 14). Dual specific antibodies are useful in inflammatory diseases. p.23 and 54, Table 21, Adams teach the same antibody format using OX40 binding antibody and human serum albumin binding antibody. Adams also teach the same antibody as claimed in the instant claim 22. Note the sequence alignment below.
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RESULT 5
AXX48001
(NOTE: this sequence has 1 duplicate in the database searched)
ID AXX48001 standard; protein; 119 AA.
XX
AC AXX48001;
XX
DT 27-MAY-2010 (first entry)
XX
DE Murine domain antibody heavy chain (mdAbH1) protein SEQ:78.
XX
KW age related macular degeneration; allergic rhinitis; antiallergic;
KW antiarthritic; antibody; antidiabetic; anti-inflammatory; antipsoriatic;
KW antiulcer; asthma; atopic dermatitis; bladder cancer; breast tumor;
KW cataract; crohns disease; cytostatic; dermatological;
KW diabetic nephropathy; domain antibody heavy chain;
KW end-stage renal disease; endocrine-gen.; fibrosis; gastrointestinal-gen.;
KW graft versus host disease; gynecological; hepatotropic; hypertension;
KW hypotensive; iga nephropathy; immune disorder; immunomodulator;
KW immunosuppressive; inflammatory disease; insulin dependent diabetes;
KW intestine disease; keloid; liver cirrhosis; lung tumor; mdAbH1;
KW metabolic-gen.; multiple sclerosis; musculoskeletal-gen.; nephrotropic;
KW neuroprotective; ophthalmological; otorhinolaryngological-gen.;
KW ovary tumor; pancreas tumor; peritoneal disease; prostate tumor;
KW protein therapy; psoriasis; psoriatic arthritis; recombinant protein;
KW renal tumor; respiratory-gen.; retinopathy; rheumatoid arthritis;
KW scleroderma; skin burns; skin ulcer; stomach tumor; surgical procedure;
KW surgical-gen.; systemic lupus erythematosus; therapeutic;
KW transplantation; ulcerative colitis; vasculitis; vasotropic; vulnerary.
XX
OS Mus sp.
XX
CC PN WO2010035012-A1.
XX
CC PD 01-APR-2010.
XX
CC PF 25-SEP-2009; 2009WO-GB002310.
XX
PR 26-SEP-2008; 2008GB-00017704.
PR 26-MAR-2009; 2009GB-00005314.
XX
CC PA (UNIO ) UCB PHARMA SA.
XX
CC PI Adams R, Hancock L, Heywood SP;
XX
DR WPI; 2010-D74880/25.
XX
CC PT New multivalent antibody fusion protein to treat e.g. asthma and cancer
CC PT comprises immunoglobulin moiety with specificity for desired antigen, and
CC PT disulfide bond linked two single domain antibodies with specificity for
CC PT other desired antigen.
XX
CC PS Disclosure; SEQ ID NO 78; 92pp; English.
XX
CC The present invention relates to a new multivalent antibody fusion
CC protein that comprises an immunoglobulin moiety selected from fraction
CC antigen binding (Fab) or Fab' fragment, with a first specificity for an
CC antigen of interest, and further comprises two single domain antibodies
CC (dAb) with specificity for a second antigen of interest, where the two
CC single domain antibodies are linked by a disulfide bond. The fusion
CC protein is useful for treating inflammatory and immune disease and
CC disorders (including rheumatoid arthritis, psoriatic arthritis, still's
CC disease, Muckle Wells disease, psoriasis, Crohn's disease, ulcerative
CC colitis, systemic lupus erythematosus, asthma, allergic rhinitis, atopic
CC dermatitis, multiple sclerosis, vasculitis, Type I diabetes mellitus,
CC transplantation and graft-versus-host disease), fibrotic disorders
CC (including idiopathic pulmonary fibrosis (IPF), systemic sclerosis (or
CC scleroderma), kidney fibrosis, diabetic nephropathy, immunoglobulin A
CC (IgA) nephropathy, hypertension, end-stage renal disease, peritoneal
CC fibrosis (continuous ambulatory peritoneal dialysis), liver cirrhosis,
CC age-related macular degeneration (ARMD), retinopathy, cardiac reactive
CC fibrosis, scarring, keloids, burns, skin ulcers, angioplasty, coronary
CC bypass surgery, arthroplasty and cataract surgery) and cancers (e.g.
CC breast, ovary, prostate, lung, kidney, pancreas, stomach, bladder or
CC bowel cancers). The present sequence represents a murine domain antibody
CC heavy chain (mdAbH1) protein used in the production of dual specificity
CC antibody fusion proteins as described in the invention.
XX
SQ Sequence 119 AA;
Query Match 88.6%; Score 189.6; Length 119;
Best Local Similarity 47.0%;
Matches 39; Conservative 0; Mismatches 0; Indels 44; Gaps 2;
Qy 1 GIDLSNYAIN--------------IIWASGTTFYATWAKG-------------------- 26
|||||||||| ||||||||||||||||
Db 26 GIDLSNYAINWVRQPPGKGLEWIGIIWASGTTFYATWAKGRFSISRDSTTVFLKMNSLQT 85
Qy 27 ----------TVPGYSTAPYFDL 39
|||||||||||||
Db 86 DDTARYYCARTVPGYSTAPYFDL 108
Adams does not teach antibodies binding to IL13 and IL22.
However, Na teaches an anti-IL13 and an anti-IL22 antibodies are tested for clinical use and a bispecific antibody is also being tested for FDA approval. Note Table II.
Therefore, it would have been obvious to one of ordinary skill in the art to arrive at the claimed invention with a reasonable expectation of success, since Adams teaches a multi-specific antibody format that can be used transferring clinically successfully anti-IL-13/22 taught by Na. One of ordinary skill in the art would have been motivated to use the format to make multi-specific antibodies since Adams teaches how to create the multi-specific antibodies recombinantly. An anti-IL-13/22 can be created using the Adams’ format by transferring the already tested IL-13/22 antibodies. One of ordinary skill in the art would recognize Adams’ multi-specific antibody would increase in vivo half-life since an anti-HSA is included in the format.
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 1-3,5-10, 16-18, 21 47, 53, 56-58, 83, 87, and 90-92 are rejected on the ground of nonstatutory double patenting as being unpatentable over now allowed claims1-4, 6, 7, 9, and 22 and 30 of US/17786996 of in view of Na of record.
The instant claimed invention differs from the invention claimed in the allowed claims in that one binding target of the multi-specific antibodies is IL-17 for the allowed claims and IL-22 for the instant claims. The allowed antibody binds to IL-13, IL-17 and human serum albumin. The instantly claimed antibody binds to IL-13, IL-22 and human serum albumin. However, Na teaches that an IL-22 binding antibody. See above under 103 rejection for Na’s teaching. Therefore, it would have been obvious to one of ordinary skill in the art to arrive at the claimed invention to switch out IL-17 binding antibody for IL-22 binding antibody. One of ordinary skill in the art would have been able to arrive at the claimed invention since the allowed claims teach how to make multi-specific antibodies. Note the antibody format in allowed claim 1 and that of instant claim 17 are same. As the sequence alignment below shows the claimed IL-13 antibody is same as the allowed antibody binding to IL-13.
RESULT 1
US-17-786-996-28
(NOTE: this sequence has 2 duplicates in the database searched)
Sequence 28, US/17786996
Publication No. US20230087378A1
GENERAL INFORMATION
APPLICANT: UCB Biopharma SRL
TITLE OF INVENTION: MULTI-SPECIFIC ANTIBODY WITH BINDING SPECIFICITY FOR HUMAN IL-13
TITLE OF INVENTION: AND IL-17
FILE REFERENCE: 31260/57986
CURRENT APPLICATION NUMBER: US/17/786,996
CURRENT FILING DATE: 2022-06-17
PRIOR APPLICATION NUMBER: PCT/EP2020/087046
PRIOR FILING DATE: 2020-12-18
PRIOR APPLICATION NUMBER: GB 1919061.0
PRIOR FILING DATE: 2019-12-20
NUMBER OF SEQ ID NOS: 68
SEQ ID NO 28
LENGTH: 116
TYPE: PRT
ORGANISM: Artificial Sequence
FEATURE:
OTHER INFORMATION: recombinant sequence
Query Match 87.4%; Score 170.4; Length 116;
Best Local Similarity 42.5%;
Matches 34; Conservative 0; Mismatches 0; Indels 46; Gaps 2;
Qy 1 GYSFTSYYIH--------------RIGPGSGDINYNEKFKG------------------- 27
|||||||||| |||||||||||||||||
Db 26 GYSFTSYYIHWVRQAPGQGLEWMGRIGPGSGDINYNEKFKGRATFTVDKSTSTAYMELSS 85
Qy 28 -------------FHYDGAD 34
|||||||
Db 86 LRSEDTAVYYCARFHYDGAD 105
Allowable Subject Matter
Claims 34 and 43 are 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. A claim drawn to a polynucleotide, a vector, a host cell, and a method of treatment would be also allowable, if they depend on allowable claims.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Misook Yu whose telephone number is (571)272-0839. The examiner can normally be reached M-Th, 7-5pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Patricia Mallari can be reached at 571-272-4729. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MISOOK YU/Supervisory Patent Examiner, Art Unit 1641