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 Claims
Claims 6, 14-16, 18, 20-23, 26, and 28-32 have been withdraw as being directed to a non-elected invention. Claims 1, 5, 7, 13, 24 and 25 are under examination at this time.
Withdrawn Rejections
The rejection of claims 1 and 5 under 35 U.S.C. 102(a)(1) as being anticipated by Rappuoli et al. (WO 2004/092360; published October 28, 2004) has been withdrawn in view of applicant’s amendments to claim 1 to delete reference to SEQ ID NO: 1.
The rejection of claims 7, 13 and 24-25 under 35 U.S.C. 103 as being unpatentable over Rappuoli et al. (WO 2004/092360; published October 28, 2004) has been withdrawn in view of applicant’s amendments to claim 1 to delete reference to SEQ ID NO: 1.
Claim Rejections - 35 USC § 102
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.
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.
Claim(s) 1 and 5 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Gaynor et al. (WO 2021/188969; effectively filed 3/20/2020).
The instant claims are directed to a peptide of less than 15 amino acids having cytotoxic T cell (CTL)- inducing ability, which comprises the amino acid sequence selected from the group consisting of:
(1) the amino acid sequence of SEQ ID NO: 3; and
(2) the amino acid sequence of SEQ ID NO: 3 in which one or two amino acid substitutions are introduced, wherein the one or two amino acid substitutions have any one of the following features (i) to (iii) . . . .
Gaynor et al. discloses SEQ ID NO: 3779, which is less than 15 amino acids, and which comprises instant SEQ ID NO: 3 (see the sequence listing of Gaynor et al. and see the alignment below) [claim 1(part 1)].
PN WO2021188969-A2.
XX
PD 23-SEP-2021.
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PF 19-MAR-2021; 2021WO-US023267.
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PR 20-MAR-2020; 2020US-0992666P.
PR 18-MAY-2020; 2020US-0026559P.
PR 31-JUL-2020; 2020US-0059582P.
PR 01-OCT-2020; 2020US-0086519P.
PR 08-DEC-2020; 2020US-0122904P.
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PA (BION-) BIONTECH US INC.
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PI Gaynor RB, Srinivasan L, Poran A, Harjanto D, Kuksin C;
PI Rothenberg DA, Srouji J;
Query Match 100.0%; Score 58; Length 11;
Best Local Similarity 100.0%;
Matches 10; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1 FVLWAHGFEL 10
||||||||||
Db 2 FVLWAHGFEL 11
Gaynor et al. also discloses SEQ ID NO: 8462, which consists of instant SEQ ID NO: 3 (see the sequence listing of Gaynor et al.) [claim 5].
Claim Rejections - 35 USC § 103
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.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 7, 13 and 25 are rejected under 35 U.S.C. 103 as being unpatentable over Gaynor et al. (WO 2021/188969; effectively filed 3/20/2020).
The instant claims are directed to a composition comprising a pharmaceutically acceptable carrier and at least one active ingredient selected from the group consisting of (a) to (e) below:
(a) one or more types of peptides of claim 1;
(b) one or more types of polynucleotides encoding the peptide(s) of claim 1 in an expressible form;
(c) an antigen-presenting cell (APC) that presents on its cell surface a complex of the peptide of claim 1 and an HLA antigen;
(d) an exosome that presents on its cell surface a complex of the peptide of claim 1 and an HLA antigen; and
(e) a CTL that targets the peptide of claim 1.
Regarding claim 7, Gaynor et al. teaches that the invention relates to a large selection of viral epitope peptide and HLA pairs generated as an information library where the viral epitope : HLA pairs are ranked based on the binding affinity and presentation prediction value (PPV). Gaynor et al. further states that in one embodiment, provided herein is an immunogenic composition, e.g., a vaccine composition capable of raising a viral epitope-specific response (e.g., a humoral or cell-mediated immune response). In some embodiments, the immunogenic composition comprises viral epitope therapeutics (e.g., peptides, polynucleotides, TCR, CAR, cells containing TCR or CAR, dendritic cell containing polypeptide, dendritic cell containing polynucleotide, antibody, etc.) described herein corresponding to viral-specific viral epitope identified herein (see paragraphs [000226] to [000227], [000233] to [000243] and [000333]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use any of the disclosed antigens/peptides in an immunogenic composition for inducing an immune response. One would have been motivated to do so and there would have been a reasonable expectation of success given the teachings of Gaynor et al. outlined above.
Claim 13 merely states that the composition of claim 7 is formulated for administration to a subject. Accordingly, claim 13 is interpreted as having the same scope as claim 7.
Regarding claim 25, Gaynor et al. teaches that the viral epitope therapeutic described herein can be provided in kit form together with instructions for administration. Typically, the kit would include the desired antigen therapeutic in a container, in unit dosage form and instructions for administration. Additional therapeutics, for example, cytokines, lymphokines, checkpoint inhibitors, antibodies, can also be included in the kit. Other kit components that can also be desirable include, for example, a sterile syringe, booster dosages, and other desired excipients (see paragraph [000378]).
Gaynor et al. further teaches that compositions can further comprise an immune modulator or adjuvant. In another embodiment, the immune modulator is a co-stimulatory ligand, a TNF ligand, an lg superfamily ligand, CD28, CD80, CD86, ICOS, CD4OL, OX40, CD27, GITR, CD30, DR3, CD69, or 4-lBB. In another embodiment, the composition further comprises an adjuvant selected from the group consisting of: Poly(I:C), Poly-ICLC, STINGagonist, 1018 ISS, aluminum salts, Amplivax, AS15, BCG, CP-870,893, CpG7909, CyaA, dSLIM, GM-CSF, IC30, IC31, Imiquimod, ImuFact IMP321, IS Patch, ISS, ISCOMATRIX, Juvlmmune, LipoVac, MF59, monophosphoryl lipid A, Montanide IMS 1312 VG, Montanide ISA 206 VG, Montanide ISA 50 V2, Montanide ISA 51 VG, OK-432, OM-174, OM-197-MPEC, ISA-TLR2 agonist, ONTAK, PepTel® vector system, PLG microparticles, resiquimod, SRLl 72, virosomes and other virus-like particles, YF-l 7D, VEGF trap, R848, beta-glucan, Pam3Cys, Pam3CSK4, acrylic or methacrylic polymers, copolymers of maleic anhydride, and QS2l stimulon. In another embodiment, the adjuvant induces a humoral when administered to a subject. In another embodiment, the adjuvant induces a T helper cell type 1 when administered to a subject.
It would have been obvious to one of ordinary skill in the art at the time the invention was made to also include in the kit an adjuvant as a “desired excipient”. One would be motivated to do this given the teachings of Gaynor et al. that other components can be included in the kit and given the teaching that immune modulators or adjuvants are useful for including in the immunogenic compositions.
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.
Claim(s) 24 is rejected under 35 U.S.C. 103 as being unpatentable over Gaynor et al. (WO 2021/188969; effectively filed 3/20/2020) as applied to claims 1, 5, 7, 13 and 25 above, and further in view of Rappuoli et al. (WO 2004/092360; published 10/28/2004).
The instant claims are directed to an emulsion comprising one or more types of peptides of claim 1, a water-soluble carrier and an oil adjuvant.
The teachings of Gaynor et al. are outline above and incorporated herein. Gaynor et al. does not teach an emulsion comprising one or more types of peptides of claim 1, a water-soluble carrier and an oil adjuvant. However, Rappuoli et al. teaches vaccine formulations comprising one or more SARS virus antigens and one or more other respiratory virus antigens (see page 3, lines 20-21). Rappuoli et al. also teaches that the T-epitopes identified in SEQ ID NOs: 7801-8040 are polypeptides for use as an antigen (see page 44, lines 29-32). Rappuoli et al. further teaches that the disclosed compositions can also contain adjuvants and a particularly preferred adjuvant for use in the compositions is an oil-in-water emulsion (see page 163, lines 29-30).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine any of the disclosed antigens/peptides from Gaynor et al. with any known adjuvant, such as the oil-in-water emulsion disclosed as a preferred adjuvant by Rappuoli et al., and the result would be predictable [an enhanced immune response].
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.
Conclusion
No claim is allowed.
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 Nicole Kinsey White whose telephone number is (571)272-9943. The examiner can normally be reached M to Th 6:30 am to 6:00 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Thomas Visone can be reached at 571-270-0684. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/NICOLE KINSEY WHITE/Primary Examiner, Art Unit 1672
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