DETAILED ACTION
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 the Application
The claims and election of 7 August 2026 are entered.
Claims 1-15, 20, 21, 23-25, and 27-182 have been canceled. Claims 16-19, 22, 26, and 183-196 are pending. Claims 191-195 are withdrawn without traverse. Claims 16-19, 22, 26, 183-190, and 196 are being examined on the merits.
Election/Restrictions
Applicant’s election of Group I (claims 16-19, 22, 26, 183-190, and 196) in the reply filed on 7 August 2026 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Claims 191-195 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 7 August 2026.
Drawings
The drawings are objected to because Figures 1B, 3A, 3E, 22B, 24, and 27 fail to comply with sequence disclosure rules. Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
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 – Nucleotide and/or amino acid sequences appearing in the drawings 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.
Specification
The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code. Applicant is required to delete the embedded hyperlink and/or other form of browser-executable code; references to websites should be limited to the top-level domain name without any prefix such as http:// or other browser-executable code. See MPEP § 608.01.
Claim Objections
Claim 187 is objected to because of the following informalities: IgG antibodies is repeated twice. Appropriate correction is required.
Claim Rejections - 35 USC § 112
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 187-190 and 196 are 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.
With respect to claim 187, the claim is indefinite because it recites a combination of “IgG antibodies, IgG antibodies”. It is unclear what combination can exist since only IgG antibodies are claimed as an option.
Claims 188-190 and 196 are all linked to canceled claim 1. Since claim 1 has been canceled, it is not possible to ascertain the metes and bounds of what is being claimed.
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.
1. Claims 16, 19, 22, 26, 183, 184, and 187 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 7 and 11 of U.S. Patent No. 10,921,324 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because the ‘324 patent claims an overlapping histone H1.0 peptide.
The ‘324 patent claims a histone H1.0 peptide containing a dimethylated lysine residue, specifically at residue K180 (see e.g. Claim 7). This overlaps with claim 16.
With respect to claim 19, ‘324 does not claim any further dimethyl groups.
With respect to claim 22, ‘324 claims SEQ ID NOs: 3-35 (see e.g. claim 11).
With respect to claim 26, this represents an inherent property of the K180 dimethylated histone H1.0 proteins as claimed by ‘324.
With respect to claim 183, the peptides of ‘324 read upon the length of 5-30 amino acids.
With respect to claim 184, as noted above ‘324 already claims SEQ ID NOs: 3-35.
With respect to claim 187, autoantibodies are generally present as IgM or IgG autoantibodies, i.e. the options for H1.0K180me2 autoantibodies are inherent to their production (see as evidence Boes et al. Proc. Natl. Acad. Sci. 97:1184-1189, published 2000).
2. Claims 16, 17, 19, 22, 26, 183-185, and 187 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 48, 50, 52, and 54 of copending Application No. 18/983,262 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the ‘262 application claims overlapping compositions.
The ‘262 application claims a kit containing a histone H1.0 protein dimethylated at K180 (see e.g. claim 48). This overlaps with claim 16.
With respect to claim 17, ‘262 claims a label (see e.g. claim 52).
With respect to claim 19, ‘262 does not claim that any other residues are dimethylated.
With respect to claim 22, ‘262 claims SEQ ID NOs: 3-35 (see e.g. claim 54).
With respect to claim 26, ‘262 claims that the peptide can bind to autoantibodies (see e.g. claim 51).
With respect to claim 183, the sequences of ‘262 are 5-30 residues in length.
With respect to claim 184, as noted above ‘262 claims overlapping sequences.
With respect to claim 185, ‘262 claims binding to a bead, column, resin, or microplate (see e.g. claim 50).
With respect to claim 187, as noted above the autoantibody form is inherent to their production.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
3. Claims 18 and 186 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 48, 50, 52, and 54 of copending Application No. 18/983,262 in view of Wysocka J (Methods 40:339-343, published December 2006, hereafter referred to as Wysocka).
The relevance of ‘262 with respect to claim 16 is set forth above.
The difference between the ‘262 application and the claimed invention is that ‘262 while claiming labeled histone H1.0 peptides does not claim biotinylation or conjugation to an active agent.
The Wysocka art discloses use of biotin conjugated to histone peptides in order to utilize the biotin-avidin binding interaction (see e.g. Figure). The histone peptide is bound to a resin (see e.g. Section 2.1).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the labeled conjugate of ‘262 by utilizing biotin as the label in order to take advantage of the strong binding between avidin and biotin as demonstrated for histone peptides by Wysocka. The rationale comes from Wysocka specifically suggesting biotin as a histone peptide conjugate. There would have been a reasonable expectation of success because ‘262 claims a labeled histone peptide and biotin was known as a label per Wysocka. The invention would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention.
With respect to claim 186, biotin can reasonably be considered a drug
This is a provisional nonstatutory double patenting rejection.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ZACHARY J MIKNIS whose telephone number is (571)272-7008. The examiner can normally be reached Mon-Thurs 7-5.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Melissa Fisher can be reached at (571) 270-7430. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ZACHARY J MIKNIS/Patent Examiner, Art Unit 1658
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