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 .
Status of Claims
Applicant’s amendment filed on 06/23/2025 is acknowledged. Following the amendment, claims
3-10 are cancelled without prejudice or disclaimer. Claims 1, 11, 15, 17, 18, and 20 are amended. Claims 1-2, 11-13, 15, 17-20, and 23 are currently pending and under examination.
Claim Interpretation
Claim 1 as currently amended reads “…wherein the modification(s) comprise a modification at amino acid position 222 wherein the amino acid position is numbered according to the numbering in SEQ ID NO: 1, and the modification comprises 222 C, D, or E.” In Applicant’s arguments, see pgs. 5-10, filed on 06/23/2025, Applicant describes SEQ ID NO:1 and the boundaries of claim 1 based on SEQ ID NO: 1 as listed in the specification (see pg. 7). SEQ ID NO: 1 as described in the specification shows serine as the residue of mutation at site 222.
However, reciting “SEQ ID NO:1” in the claim refers to the sequence in the sequence listing, not the sequence in the specification; 37 CFR 1.821(d). The sequence in the sequence listing has a lysine at residue 222. Towards the N-terminus, the next amino acid (residue 221) is proline, and towards the C-terminus (residue 223) is serine. Therefore, what Applicant is actually claiming are variants where the K (lysine) is replaced with C, D, or E.
Nucleotide and/or Amino Acid Sequence Disclosures
Summary of Requirements for Patent Applications Filed On Or After July 1, 2022, That Have Sequence Disclosures
37 CFR 1.831(a) requires that patent applications which contain disclosures of nucleotide and/or amino acid sequences that fall within the definitions of 37 CFR 1.831(b) must contain a “Sequence Listing XML”, 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 1.831-1.835. This “Sequence Listing XML” part of the disclosure may be submitted:
1. In accordance with 37 CFR 1.831(a) using the symbols and format requirements of 37 CFR 1.832 through 1.834 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”) in XML format, together with an incorporation by reference statement of the material in the XML file in a separate paragraph of the specification (an incorporation by reference paragraph) as required by 37 CFR 1.835(a)(2) or 1.835(b)(2) identifying:
a. the name of the XML file
b. the date of creation; and
c. the size of the XML file in bytes; or
2. In accordance with 37 CFR 1.831(a) using the symbols and format requirements of 37 CFR 1.832 through 1.834 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 statement of the material in the XML format according to 37 CFR 1.52(e)(8) and 37 CFR 1.835(a)(2) or 1.835(b)(2) in a separate paragraph of the specification identifying:
a. the name of the XML file;
b. the date of creation; and
c. the size of the XML file in bytes.
SPECIFIC DEFICIENCIES AND THE REQUIRED RESPONSE TO THIS NOTICE ARE AS FOLLOWS:
This application contains sequence disclosures in accordance with the definitions for nucleotide and/or amino acid sequences set forth in 37 CFR 1.831(a) and 1.831(b). However, this application fails to comply with the requirements of 37 CFR 1.831-1.834. The examiner previously noted these deficiencies on pgs. 3-4 of the office action mailed 03/21/2025. Applicant arguments in remarks filed on 06/23/2025 have been considered and Examiner proposes that Applicant can resolve many of the issues discussed in those remarks by submitting a new sequence listing which has a variable residue at position 216. Currently, residues 215-220 are Asp-Lys-Thr-Arg-Val-Glu. Applicant can use the software to change this to Asp-(Lys/Thr)-Arg-Val-Glu in accordance with the specification. See MPEP 2412.05(c).
Applicant must provide:
• A replacement “Sequence Listing XML” part of the disclosure, as described above in item 1. or 2., as well as
• A statement that identifies the location of all additions, deletions, or replacements of sequence information in the “Sequence Listing XML” as required by 1.835(b)(3);
• A statement that indicates support for the amendment in the application, as filed, as required by 37 CFR 1.835(b)(4);
• A statement that the “Sequence Listing XML” includes no new matter in accordance with 1.835(b)(5); and
• A substitute specification in compliance with 37 CFR 1.52, 1.121(b)(3), and 1.125 inserting the required incorporation by reference paragraph as required by 37 CFR 1.835(b)(2), consisting of:
o A copy of the previously-submitted specification, with deletions shown with strikethrough or brackets and insertions shown with underlining (marked-up version);
o 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
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.
In view of Applicant’s amendment filed on 06/23/2025, claims 1-2, 11-13, 15, 17-20, and 23 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.
Amended claim 1 now reads “…wherein the modification(s) comprise a modification at amino acid position 222 wherein the amino acid position is numbered according to the numbering in SEQ ID NO: 1, and the modification comprises 222 C, D, or E.” Applicant’s original sequence listing was not filed the same day as the original disclosure. Sequence listing was filed one day after the disclosure (9/28/21 vs 9/29/21).
Therefore, the originally-filed disclosure did not contemplate mutating the lysine at position 222 to C, D, or E and claim 1 and claims 2, 11-13, 15, 17-20, and 23 which depend from claim 1, contain 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 inventors, at the time the application was filed, had possession of the claimed invention.
Applicant’s arguments, see pgs. 5-10, filed 06/23/2025, with respect to the rejection of claims 3-11 under 35 U.S.C. 112(a) and claims 14-18, 20, and 23 U.S.C. 112(b) as set forth on pgs. 2-5 of the office action mailed on 03/21/2025 have been fully considered and are persuasive. Therefore, these rejections have been withdrawn.
However, upon further consideration and in view of Applicant’s amendment, a new ground of
rejection is necessitated under 35 U.S.C. 112(b) and 35 U.S.C. 112(d).
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 1-2, 11-13, 15, 17-20, and 23 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.
Claims 1 and 12 recite the phrase “at least about 50% less proteolysis…under suitable conditions.” The use of the phrase “at least about” renders the claims indefinite because it renders the scope encompassed by the claim unclear and what significance is allocated for each of the limitations following the phrase. See MPEP § 2173.05(d). The metes and bounds of the claim are unclear from the wording. Deleting “about” from the claim would rectify this rejection.
Claims 2, 11, 13, 15, 17-20, and 23 are rejected indefinite insofar as they depend on claim 1 the for their limitations but do not rectify its deficiencies.
Claim Rejections - 35 USC § 102
Applicant’s arguments, see pgs. 10-11, filed 06/23/2025, with respect to the rejection of claims 1-4, 12-13, 18-20, and 23 under 35 U.S.C. 102(a)(1) and 35 U.S.C. 102(a)(2) as being anticipated by Brezski et al. (US8871204B2) have been fully considered and are persuasive. Therefore, the rejection of these claims as set forth on the office action mailed on 03/21/2025 has been withdrawn.
Claim Rejections - 35 USC § 103
Applicant’s arguments, see pgs. 11-13, filed 06/23/2025, with respect to the rejection of claims 1-4, 5-11, and 23 are rejected under 35 U.S.C. 103 as being unpatentable over Brezski et al. (US8871204B2), as applied to claims 1-4, 12-13, 18-20, and 23 above, and further in view of Boxu Yan et al. (Journal of Biological Chemistry, 2011, 287(8):5891-5897) and Tao Xiang et al. (Journal of Chromatography B, 2007, 858(1-2):254-262) have been fully considered and are persuasive. Therefore, the rejection of these claims as set forth on the office action mailed on 03/21/2025 has been withdrawn.
In addition, Applicant’s arguments, see pgs. 13-14, filed 06/23/2025, with respect to the rejection of claims 1-20, and 23 under 35 U.S.C. 103 as being unpatentable over Brezski et al. (cited above), Boxu Yan et al. (cited above), and Tao Xiang et al. (cited above) as applied to claims 1-4, 5-11, 12-13, 18-20, and 23 above, and further in view of Rantasalo et al. (Scientific Reports, 2019, 9(5032):1-12) have been fully considered and are persuasive. Therefore, the rejection of these claims as set forth on the office action mailed on 03/21/2025 are also withdrawn.
Double Patenting
In light of Applicant’s amendment and Applicant’s arguments, filed on 06/23/2025, the provisional rejection of claims 1-20 and 23 on the ground of nonstatutory double patenting as being unpatentable over claims 1, 5-9, and 11-12 of copending Application No. 17/915,883 (‘883) in view of Brezski et al. (cited above), Boxu Yan et al. (cited above), and Tao Xiang et al. (cited above) has been withdrawn.
Allowable Subject Matter
In light of Applicant’s amendment and Applicant’s arguments, filed on 06/23/2025, claims 1-2, 11-13, 15, 17-20, and 23 are free of the prior art and are allowable pending rejections listed above. The closest prior art taught by Saunders (Frontiers in Immunology, 2019, 10(1296):1-20) recites upper hinge 222 modifications that are targeted toward C1q/Complement-Dependent Cytotoxicity (CDC) activity, but makes makes no mention of 222 C/D/E substitution to increase manufacturability benefit by reducing proteolysis during production.
Conclusion
No claim is allowable.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DENNIS GEORGE whose telephone number is (571)270-0340. The examiner can normally be reached M-F 8:30am - 5pm EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Daniel E Kolker can be reached at (571) 272-3181. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/DENNIS GEORGE/Examiner, Art Unit 1644
/DANIEL E KOLKER/Supervisory Patent Examiner, Art Unit 1644