DETAILED ACTION
Notice of Pre-AIA or AIA Status
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
2. Applicant's reply filed on 11/28/2025 is acknowledged.
3. Claims 22-24 are new. Claims 1-9, 11-15 and 22-24 are pending. Claims 10 and 16-21 are canceled. Claims 5-7, 9 and 11-15 are withdrawn. Claims 1-5, 7-9 and 11 are amended.
4. Claims 1-4, 8 and 22-24 are under examination.
Information Disclosure Statement
5. The information disclosure statement (IDS) submitted on 11/28/2025 has been considered by the examiner.
Objections Maintained
Nucleotide and/or Amino Acid Sequence Disclosures
6. 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:
• 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.
7. Specific deficiency – Nucleotide and/or amino acid sequences appearing in the drawings are not identified by sequence identifiers in accordance with 37 CFR 1.821(d). See Figs. 3 and 6. 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.
Examiner’s Comments: The objection to Figs. 3 and 6 is maintained. In the reply filed on 11/28/2025, applicant did not add sequence identifiers for nucleotide and/or amino acid sequences shown in Figs. 3 and 6 in the drawings or in the Brief Description of the Drawings.
8. 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.
Examiner’s Comments: The objection is maintained because applicant did not address the issue in the reply filed on 11/28/2025.
Objections Withdrawn
9. The objection to Fig. 17 is withdrawn in view of applicant’s submission of a replacement sheet.
10. The objection to the disclosure because it contains an embedded hyperlink and/or other form of browser-executable code is withdrawn in view of applicant’s amendments.
11. The objection to claim 1 for informalities is withdrawn in view of applicant’s amendments.
Rejections Withdrawn
12. The rejection of claims 1-4 and 8 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for reciting “selected from the group comprising H268, S267, P271, G327, or a combination thereof” is withdrawn in view of applicant’s amendments.
13. The rejection of claim 8 under 35 U.S.C. 102(a)(1) as being anticipated by Lazar et al. (US 8,809,503 B2, date of patent: 8/19/2014) is withdrawn in view of applicant’s amendments.
14. The rejection of claims 1-4 and 8 under 35 U.S.C. 102(a)(1) as being anticipated by Li et al. (WO 2017/211321A1, pub. date: 12/14/2017, English equivalent: US 2019/0263918A1, pub date: 8/29/2019 is withdrawn in view of applicant’s amendments.
15. The rejection of claims 1-4 and 8 on the ground of nonstatutory double patenting as being unpatentable over claims 1-18 of U.S. Patent No. 12,145,993 B2 is withdrawn in view of applicant’s amendments.
Rejections Maintained
Claim Rejections - 35 USC § 102
16. 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.
17. Claims 1-4, 8, and new claims 22-24 remain/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Chu et al. (US 2009/0042291A1, pub. date 2/12/2009).
Regarding claims 1 and 2, Chu et al. teaches an Fc variant which has enhanced binding affinity to Fc[Symbol font/0x67]RIIb relative to parent polypeptide and comprise a mutation at L328 (claims), wherein the mutation at L328 includes L328W, wherein the numbering of the residues in the Fc region is that of the EU index as in Kabat ([0417]), wherein the Fc variant is human IgG2 Fc variant ([0191], [0195], [0395]).
Regarding claims 3-4, Chu et al. teaches an Fc region, an antibody or Fc fusion polypeptide comprising the Fc variant ([0189]).
Regrading claim 8 and new claim 22-24, Chu et al. teaches a composition comprising a Fc polypeptide that comprise the Fc variant described therein, and a physiologically or pharmaceutically acceptable carrier or diluent ([0036]), wherein the Fc polypeptide includes an antibody and a Fc fusion protein ([0020], and [0172]).
The instant SEQ ID NO:20 contains Leucine at position 328 according to EU numbering. L328W is a mutation with respect to wild-type IgG2 Fc (instant SEQ ID NO: 20).
Applicant’s Arguments
The response states that Chu et al. does not disclose the specific combination of V234Q and L328W. While Chu et al. may disclose lists of hundreds of potential mutations, including L328W, it does not disclose the specific combination of V234Q and L328W in a human IgG2 Fc region. Amended Claim 1 now explicitly requires the mutation V234Q (correcting the typographical error "34Q"). The wild-type residue at position 234 in human IgG2 is Valine (V). The mutation to Glutamine (Q) at this position creates a distinct structural variant. Selecting V234Q and L328W simultaneously from these disparate lists would require improper "cherry-picking" of elements without a specific teaching in the reference to combine them in this specific manner for an IgG2 antibody. The claimed invention is a specific IgG2 mutant (V234Q/L328W) that exhibits superior properties (e.g., enhanced FcyRIIb binding). Because Chu et al. does not describe this specific combination, it cannot anticipate the claim.
Response to Arguments
Applicant’s arguments have been carefully considered but are not persuasive because the claims are not limited to a mutant IgG2 Fc polypeptide comprising V234Q/L328W mutations. Applicant elected species L328W on 8/14/2025 in response to restriction requirement. The first embodiment of claim 1 is a mutant IgG2 Fc polypeptide comprising L328W. The prior art teach a mutant IgG2 Fc polypeptide comprising L328W (see the rejection), as such it anticipates one of the embodiments of the claims.
New Grounds of Objection and Rejection
Claim Objections
18. Claim 1 is objected to for a grammatical error. In the phrase “wherein said mutant IgG2 Fc polypeptide fragment has a mutation is selected from…” (line 6), the word “is” should be deleted or changed to “which is”.
Claim 1 is further objected to for reciting “V234Q/V266L/S267E/H268S/E269V”. The combination does not include L328 mutation, which is specifically required in the claim (see line 3).
Claim Rejections - 35 USC § 102
19. 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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
20. Claims 1-4, 8, and new claims 22-24 are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Lazar et al. (US 2018/0360981A1, pub. date 12/20/2018, effectively filed date: at least 3/13/2014).
Regarding claims 1 and 2, Lazar et al. teaches an IgG2 Fc variant which comprises L328W mutation ([0029], [0031] and [0034]), wherein the numbering of the residues in the Fc region is that of the EU index as in Kabat ([0012]), wherein the Fc variant is human IgG2 Fc variant ([0278]). An IgG2 Fc variant comprising L328W mutation would inherently have enhanced binding affinity to Fc[Symbol font/0x67]RIIb relative to parent polypeptide and
Regarding claims 3-4, Chu et al. teaches an Fc region, an antibody or Fc fusion polypeptide comprising the Fc variant ([0082]).
Regrading claim 8 and new claim 22-24, Chu et al. teaches a composition comprising a Fc polypeptide comprising the Fc variant, and a physiologically or pharmaceutically acceptable carrier or diluent ([0085]), wherein the Fc polypeptide includes an antibody and a Fc fusion protein ([0253]).
The instant SEQ ID NO:20 contains Leucine at position 328 according to EU numbering. L328W is a mutation with respect to wild-type IgG2 Fc (instant SEQ ID NO: 20).
Conclusion
21. No claims are allowed.
Applicant's submission of an information disclosure statement under 37 CFR 1.97(c) with the timing fee set forth in 37 CFR 1.17(p) on 11/28/2025 prompted the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 609.04(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.
22. Any inquiry concerning this communication or earlier communications from the examiner should be directed to HONG SANG whose telephone number is (571)272-8145. The examiner can normally be reached Monday-Friday 8am-5pm.
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, Janet Epps-Smith can be reached at 5712720757. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/HONG SANG/Primary Examiner, Art Unit 1646
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