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 .
Claim Status
Applicant’s amendments and remarks, filed 9/4/2025, are acknowledged.
Claims 1-25 and 33-45 are canceled.
Claims 27-32 and 46-47 are amended.
Claims 26-32 and 46-48 are pending.
As such, claims 26-32 and 46-48 are pending examination and currently under consideration for patentability under 37 CFR 1.104.
DETAILED ACTION
Withdrawn Objections
The drawing objections are withdrawn. Issues regarding figures being cut-off have been sufficiently addressed through amendments to the drawings on 9/4/2025.
The claim objections are withdrawn. Issues regarding minor informalities have been sufficiently addressed through amendments to the claims filed on 9/4/2025.
Nucleotide and/or Amino Acid Sequence Disclosures
REQUIREMENTS FOR PATENT APPLICATIONS CONTAINING NUCLEOTIDE AND/OR AMINO ACID SEQUENCE DISCLOSURES
Items 1) and 2) provide general guidance related to requirements for sequence disclosures.
37 CFR 1.821(c) requires that patent applications which contain disclosures of nucleotide and/or amino acid sequences that fall within the definitions of 37 CFR 1.821(a) must contain a "Sequence Listing," as a separate part of the disclosure, which presents the nucleotide and/or amino acid sequences and associated information using the symbols and format in accordance with the requirements of 37 CFR 1.821 - 1.825. This "Sequence Listing" part of the disclosure may be submitted:
In accordance with 37 CFR 1.821(c)(1) via the USPTO patent electronic filing system (see Section I.1 of the Legal Framework for Patent Electronic System (https://www.uspto.gov/PatentLegalFramework), hereinafter "Legal Framework") as an ASCII text file, together with an incorporation-by-reference of the material in the ASCII text file in a separate paragraph of the specification as required by 37 CFR 1.823(b)(1) identifying:
the name of the ASCII text file;
ii) the date of creation; and
iii) the size of the ASCII text file in bytes;
In accordance with 37 CFR 1.821(c)(1) on read-only optical disc(s) as permitted by 37 CFR 1.52(e)(1)(ii), labeled according to 37 CFR 1.52(e)(5), with an incorporation-by-reference of the material in the ASCII text file according to 37 CFR 1.52(e)(8) and 37 CFR 1.823(b)(1) in a separate paragraph of the specification identifying:
the name of the ASCII text file;
the date of creation; and
the size of the ASCII text file in bytes;
In accordance with 37 CFR 1.821(c)(2) via the USPTO patent electronic filing system as a PDF file (not recommended); or
In accordance with 37 CFR 1.821(c)(3) on physical sheets of paper (not recommended).
When a “Sequence Listing” has been submitted as a PDF file as in 1(c) above (37 CFR 1.821(c)(2)) or on physical sheets of paper as in 1(d) above (37 CFR 1.821(c)(3)), 37 CFR 1.821(e)(1) requires a computer readable form (CRF) of the “Sequence Listing” in accordance with the requirements of 37 CFR 1.824.
If the "Sequence Listing" required by 37 CFR 1.821(c) is filed via the USPTO patent electronic filing system as a PDF, then 37 CFR 1.821(e)(1)(ii) or 1.821(e)(2)(ii) requires submission of a statement that the "Sequence Listing" content of the PDF copy and the CRF copy (the ASCII text file copy) are identical.
If the "Sequence Listing" required by 37 CFR 1.821(c) is filed on paper or read-only optical disc, then 37 CFR 1.821(e)(1)(ii) or 1.821(e)(2)(ii) requires submission of a statement that the "Sequence Listing" content of the paper or read-only optical disc copy and the CRF are identical.
Specific deficiencies and the required response to this Office Action are as follows:
Specific deficiency - The Incorporation by Reference paragraph required by 37 CFR 1.821(c)(1) is missing or incomplete. See item 1) a) or 1) b) above.
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.
Maintained Rejections
Claim Rejections - 35 USC § 112 New Matter
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 26-32 and 47-48 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claims 26 and 47 recite a polypeptide complex or a composition comprising a polypeptide, respectively, comprising a heavy chain variable (VH) region, wherein the VH region incorporates the following CDRs: a heavy chain-complementarity determining region (HC-CDR)1 of SEQ ID NO: 95; a HC-CDR2 of SEQ ID NO: 96 or of SEQ ID NO: 96 in which only one amino acid is substituted; and a HC-CDR3 of SEQ ID NO: 97; and (ii) a polypeptide comprising a light chain variable (VL) region, wherein the VL region incorporates the following CDRs: a light chain-complementarity determining region (LC-CDR)1 of SEQ ID NO: 101; a LC-CDR2 of SEQ ID NO: 102, or of SEQ ID NO: 102 in which only one amino acid is substituted; and a LC-CDR3 of SEQ ID NO: 103.
Claim 26 was amended to remove the “binds specifically to IL-11” limitation in the preamble. The claims are now broadened to encompass a polypeptide complex or a composition that can essentially bind to anything. While the specification disclose that these proteins are “capable of binding to IL-11” (see pg. 11, lines 12-21), the specification also indicates that the claimed CDRs solely bind to IL-11 with no mention that the CDRs bind to other targets (see pg. 23, lines 4-9; pg. 35, lines 20-27; Figures 47A, 47B, 54A, and 54B; pg. 143, lines 9-10; and, Example 6).
Additionally, while the specification discloses of substitutions for specific SEQ ID Nos (e.g., see pages 23-30, 35-36, 38-40, 42-45) and discloses of specific substitutions at position 91 of VL SEQ ID Nos: 7, 9, and 11 (see Example 18), the specification nor the claims indicate specific substitutions made to the CDR2 sequences as claimed.
As such, the claims are rejected for incorporating new matter.
Applicant’s Arguments
Applicant respectfully disagrees with the new matter rejection (see pages 7 and 8 of the Remarks filed on 9/4/2025). Applicant indicates there is no requirement that the polypeptides of claim 26 and claim 47 bind to anything, let alone that they bind to IL-11. The polypeptide complex of claim 26 and the composition of claim 47 are not new matter. Information contained in the specification, the claims, or the drawings of the application as filed may be added to any claims without introducing new matter. MPEP § 2163.06. The polypeptide complex of claim 26 is contained in the specification as filed on page 55, lines 13-17, lines 24-26; and the composition of claim 47 is contained in the specification as filed on page 81, lines 19-21. There is no requirement in the specification that the polypeptide complex of claim 26 and/or the composition of claim 47 bind anything. The claims therefore do not introduce new matter.
Response to Arguments
Applicant's arguments filed 9/4/2025 have been fully considered but they are not persuasive. Examiner acknowledges that the claims were amended to no longer recite “binds specifically to IL-11”. However, the specification indicates that the claimed complexes and compositions comprising the claimed CDR sequences and a variant thereof bind to IL-11 (see Figures 51A to 51C, 54A and 54B; pages 35-36). As such, removing the language introduces new matter because the specification does not support the broad claim to complexes and compositions comprising the claimed CDR sequences, or a variant thereof, that can bind to anything other than IL-11. Further, as stated in the rejection, while the specification discloses of substitutions for specific SEQ ID Nos (e.g., see pages 23-30, 35-36, 38-40, 42-45) and discloses of specific substitutions at position 91 of VL SEQ ID Nos: 7, 9, and 11 (see Example 18), the specification nor the claims indicate specific substitutions made to the CDR2 sequences as claimed. Thus, with the claims indicating that these sequences and variants thereof bind to IL-11 and the specification not providing specific substitutions to CDR2 SEQ ID Nos: 96 and 102, the amendments to the claims introduce new matter because Applicant is broadening the scope of the invention for which Applicant has not demonstrated possession of the large genus.
Therefore, the new matter rejection is maintained.
Allowable Subject Matter
Claim 46 is allowable. As stated in the previous action mailed 03/10/2025, Examiner acknowledges that Applicant submitted a terminal disclaimer for co-pending applications 18/592,746 and 18/592,665 filed 12/13/2024. Further, there is no art that teach of suggest the antibody of the present invention. Specifically, there is no art that teach or suggest the combination of CDR sequences recited in claim 46. The closest prior art is Cook et al (US 20180186871 A1, publication date: 07/05/2018; filing date: 12/15/2017; previously submitted with the Office Action mailed on 03/10/2025). Cook et al disclose of IL-11 antibodies, compositions comprising the IL-11 antibodies, and methods using the IL-11 antibodies (see Abstract). Specifically, Cook et al disclose antibody BSN-2E1 which comprises SEQ ID NO: 541 shares 88.0% identity to instant SEQ ID NO: 117, and SEQ ID NO: 554 shares 61.0% identity to instant SEQ ID NO: 122 (see alignment below).
SEQ ID NO: 117 Alignment
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221
619
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Greyscale
SEQ ID NO: 122 Alignment
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194
622
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Greyscale
Conclusion
Claim 46 is allowed.
Claims 26-32 and 47-48 are not allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DANAYA L MIDDLETON whose telephone number is (571)270-5479. The examiner can normally be reached M-F 9:30AM - 6PM with flex.
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, Vanessa Ford can be reached at (571) 272-0857. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/DANAYA L MIDDLETON/Examiner, Art Unit 1674
/VANESSA L. FORD/Supervisory Patent Examiner, Art Unit 1674