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 .
DETAILED ACTION
Acknowledgement is hereby made of receipt and entry of the communication filed on Dec. 30, 2025. Claims 1-3, 5-7, 11-13, 19-20 and 34-40 are pending. Claims 1-3, 5-7, 11 and 19-20 are withdrawn. Claims 12-13 and 34-40 are currently examined.
Election/Restrictions
Applicant's election without traverse of Group II (12-13 and 34), in the reply filed on Dec. 30, 2025, is acknowledged. The new claims 35-40 filed on Dec. 30, 2026 are also acknowledged.
For species election requirement, the applicant elected SEQ ID NOs: 19 and 24-25 from claim 12.
Accordingly, claims 1-3, 5-7, 11 and 19-20 are withdrawn as being directed to a non-elected group, and claims 12-13 and 34-40 are currently examined.
Drawing Objection
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Some Figures are difficult to read, such as the figure caption and/or labeling. Therefore, Fig. 1A, Fig. 3C, Fig. 4E. Fig. 5A-B, Fig. 7B-C, Fig. 8A-C, Fig. 9A-B, Fig. 10 A-C and Fig. 12A must be clearly labeled.
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.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 12-13 and 34-40 are rejected under 35 U.S.C. 103 as being unpatentable over Gaynor et al. (US 2023/0083931 A1, published on Mar. 16, 2023, claiming priority to US provisional application No. 62/992,666, filed on Mar. 20, 2020, hereinafter “Gaynor”).
The base claim 12 is directed to a composition comprising a plurality of antigenic peptides comprising 4 or more consecutive amino acids from epitope sequences shown in SEQ ID NOs:19, 24, and 25.
Gaynor teaches that a composition comprising: (i) a polypeptide comprising at least two of the following (a) a sequence comprising an epitope sequence from ORF 1ab, (b) a sequence comprising an epitope sequence from membrane glycoprotein (M) and (c) a sequence comprising an epitope sequence from nucleocapsid phosphoprotein (N) (See [0009]). For the 4 or more consecutive amino acids, Gaynor teaches that provided herein is a pharmaceutical composition comprising: a polypeptide comprising an epitope sequence of Table 1A, Table 1B (See [0056]). Table 1A comprises the 4 or more consecutive amino acids from epitope shown in SEQ ID NO: 19 as claimed, e.g. at KKQQTVTL (peptide set 3 at #242, page 69) and AADLDDFSKQL (peptide set 1 at #2, page 63), comprises the 4 or more consecutive amino acids from epitope shown in SEQ ID NO: 24 as claimed, e.g. at ILPDPSKPS (peptide set 3 at #168, page 67) and LLFNKVTLA (peptide set 3 at #2457, page 131), comprises the 4 or more consecutive amino acids from epitope shown in SEQ ID NO: 25 as claimed, e.g. at DSFKEELDK (peptide set 1 at #592, page 79) and VYDPLQPELDSF (peptide set 2 at #416, page 74). Here the epitope peptides teach the “a plurality of antigenic peptides…” as claimed. In addition, the consecutive amino acids taught by Gaynor here include 8 or more consecutive amino acids from the epitope sequences as claimed in claim 40.
It is noted that Gaynor’s Table 1A described above includes any epitope listed in the Table besides the epitopes presented in the SEQ ID NOs: 19 and 24-25, which does not teach the “comprising 4 or more consecutive amino acids from epitope sequences shown in SEQ ID NOs:19, 24, and 25” as claimed. However, Gaynor teaches that “provided herein is a T cell receptor (TCR) or T cell comprising a TCR that binds an epitope sequence from Table 1A or Table 1B in complex with a corresponding MHC class I molecule according to Table 1A or Table 1B. For example, the TCR can bind to an epitope sequence from column 2 (set 1) of Table 1A in complex with a corresponding MHC class I molecule from column 3 (set 1) in the same row of Table IA. For example, the TCR can bind to an epitope sequence from column 4 (set 2) of Table 1A in complex with a corresponding MHC class I molecule from column 5 (set 2) in the same row of Table IA. For example, the TCR can bind to an epitope sequence from column 6 (set 3) of Table 1A in complex with a corresponding MHC class I molecule from column 7 (set 3) in the same row of Table 1A” (See e.g., [1088]). At the same time, Gaynor teaches that a person skilled in the art will be able to select viral epitope therapeutics by testing, for example, the generation of T cells in vitro as well as their efficiency and overall presence, the proliferation, affinity and expansion of certain T cells for certain peptides, and the functionality of the T cells, e.g. by analyzing the IFN-y production or cell killing by T cells. The most efficient peptides can then combined as an immunogenic composition (See [1107]). Accordingly, it would be obvious for one of ordinary skill in the art to develop a composition combining epitopes from the SEQ ID NOs: 19, 24-25 as claimed because they are all the TCR epitopes in Table A, and the result would be predictable because they are all TCR-binding epitopes as taught by Gaynor.
Thus, the invention as a whole was clearly prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention.
Regarding claims 13 and 35-36, Gaynor teaches that the modification of the antigenic peptide is conjugate to a carrier protein, an antibody… nanoparticle…biotinylation…, f-moc amino acids… etc. (See [0888]) and in some embodiments, the peptide can be synthetically conjugated to be joined to native fragments or particles (See [1051]), where the nanoparticle/particle can be a bead for detection and the nanoparticle and biotinylaiton are both a detection moiety, and the f-moc amino acids conjugation is fluorescent (teaches claim 35). Also, Gaynor teaches that ELISPOT assay where the 1x10^5 peptide-pulsed targets are cocultured in the ELISPOT plate wells with varying concentrations of T cells (5x10^2 to 2x10^3) taken from the IVE culture. Plates are developed according to the manufacturer's protocol, and analyzed on an ELISPOT reader (See [1337]), which teaches claim 36 for the conjugated surface being a multiwell plate because the peptide is added to the plate wells.
Regarding claims 34 and 37, Gaynor teaches that the viral epitope therapeutic described herein can be provided in kit form together with instructions for administration (See [1275]), and in some embodiments, the pharmaceutical composition comprises a pharmaceutically acceptable excipient, carrier, or diluent (See [0179]).
Regarding claims 38-39, Gaynor teaches that Table 2Ai comprises the 4 or more consecutive amino acids from epitope shown in SEQ ID NO: 15 as claimed at DLPQGF (peptide set 1 at #519, page 226), and comprises the 4 or more consecutive amino acids from epitope shown in SEQ ID NO: 1039 as claimed at ASVYAWNR (peptide set 2 at #325, page 218).
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RUIXUE WANG whose telephone number is (571)272-7960. The examiner can normally be reached Monday-Friday 8:00 am to 4:30 pm, EST.
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, Thomas J. Visone can be reached on (571) 270-0684. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/RUIXUE WANG/Examiner, Art Unit 1672
/NICOLE KINSEY WHITE/ Primary Examiner, Art Unit 1672