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 .
Election/Restrictions
2. Applicant’s election without traverse of (A) SEQ ID NO: 18 as the species of peptide, and (B) Fc fragment with mutations G236A, S239D and I332E as the species of Fc in the reply filed 28 May 2026 is acknowledged. Newly added claims 12, and amended claims 10-12 are directed to an invention that lacks unity with the elected invention. Even though the methods of the amended claims require the technical feature of a hybrid molecule comprising fibrin-derived peptide having at least one citrullyl residue linked to an antibody Fc, this technical feature is not a special technical feature as it does not make a contribution over the prior art in view of Chu et al . (EP 2176298; published 15 November 2017; cited by Applicant) which discloses Fc fusions that are covalently linked to an autoantigen, including citrullinated fibrin (See column 5 [0009]).
Since applicant has received an action on the merits for the originally presented
invention, this invention has been constructively elected by original presentation for prosecution
on the merits. Accordingly, claims 10-12 are withdrawn from consideration as being directed to
a non-elected invention. See 37 CFR 1.142(b) and MPEP § 821.03. Election was made without traverse in the reply filed on 28 May 2026.
The restriction requirement is still deemed proper and is therefore made FINAL.
Status of Application, Amendments, and/or Claims
3. The Response filed on 28 May 2026 has been entered in full. Claims 2-11 have been amended, claim 12 has been added, and claims 10-12 have been withdrawn as discussed supra. Therefore, claims 1-12 are pending, and claims 1-9 are the subject of this Office Action.
Information Disclosure Statement
4. The information disclosure statements (IDS) submitted on 18 September 2023, 06 January 2026, and 12 May 2026 have been considered by the examiner.
Improper Markush
5. Claims 2, 4 and 5 are rejected on the basis that it contains an improper Markush grouping of alternatives. See In re Harnisch, 631 F.2d 716, 721-22 (CCPA 1980) and Ex parte Hozumi, 3 USPQ2d 1059, 1060 (Bd. Pat. App. & Int. 1984). A Markush grouping is proper if the alternatives defined by the Markush group (i.e., alternatives from which a selection is to be made in the context of a combination or process, or alternative chemical compounds as a whole) share a “single structural similarity” and a common use. A Markush grouping meets these requirements in two situations. First, a Markush grouping is proper if the alternatives are all members of the same recognized physical or chemical class or the same art-recognized class, and are disclosed in the specification or known in the art to be functionally equivalent and have a common use. Second, where a Markush grouping describes alternative chemical compounds, whether by words or chemical formulas, and the alternatives do not belong to a recognized class as set forth above, the members of the Markush grouping may be considered to share a “single structural similarity” and common use where the alternatives share both a substantial structural feature and a common use that flows from the substantial structural feature. See MPEP § 2117.
6. The Markush grouping of peptides is improper because the alternatives defined by the Markush grouping do not share both a single structural similarity and a common use for the following reasons: Claims 2, 4 and 5 are directed to different peptides, or peptides which comprise different epitopes of a protein. The amino acid sequences of the various peptides and epitopes are different and thus share no structural similarity and therefore, there is no substantial structural feature and a common use that flows from the substantial structural feature.
7. To overcome this rejection, Applicant may set forth each alternative (or grouping of patentably indistinct alternatives) within an improper Markush grouping in a series of independent or dependent claims and/or present convincing arguments that the group members recited in the alternative within a single claim in fact share a single structural similarity as well as a common use.
Claim Rejections - 35 USC § 112
8. 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.
9. Claim 9 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.
10. Claim 9 is rejected as being indefinite for reciting the phrase “a peptide represented by SEQ ID NO: 19 or SEQ ID NO: 18”. Without knowing whether the limitation refers to a peptide consisting of the amino acid sequence of SEQ ID NO:19, for example, a peptide comprising the amino acid sequence of SEQ ID NO:19, or a peptide typified by SEQ ID NO:19 (and to what degree, structurally and/or functionally), the metes and bounds of the claim cannot be determined.
Claim Rejections - 35 USC § 102
11. 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.
12. 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.
13. Claim(s) 1, 3 and 6-7 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Chu et al. (EP 2176298; published 15 November 2017; cited by Applicant).
14. Chu et al. discloses an Fc fusion that is covalently linked to an autoantigen, including citrullinated fibrin (See column 5 [0009]. Chu also discloses wherein the Fc region is human IgG1 and comprises two or more substitutions, including G236A, S239D and I332E (See column 6 [0010]). Chu also discloses that the Fc and peptide may be linked at any region of the Fc, including at the N- or C- termini, or at any residues in between the two termini, and further discloses a variety of linkers that can be used to covalently link the Fc and the peptide, including PEG (See columns 62-63 [0140]). Thus the reference of Chu et al. meets all the limitations of claims 1, 3 and 6-7.
Summary
30. Claims 1-7 and 9 stand rejected.
Claim 8 is 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.
Advisory Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Jon M. Lockard whose telephone number is (571) 272-2717. The examiner can normally be reached on Monday through Friday, 8:00 AM to 4:30 PM.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Joanne Hama, can be reached on (571) 272-2911. The fax number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/JON M LOCKARD/
Examiner, Art Unit 1647
August 12, 2026
Prosecution Insights