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 .
Election/Restrictions
Applicant’s election without traverse of species embodiments spike, membrane matrix, replicase and SEQ ID NO: 19, 20, 30, 32 and 37, in the reply filed on May 21, 2025 is acknowledged.
Claims Summary
Claims 1-14
Claim 1 is directed to an immunogenic composition comprising:
At least one mimetic peptide comprising:
i. An amino acid sequence conserved among beta coronaviruses from elected species spike (S) protein domain groups, membrane matrix (MM) protein and replicase (Rep) protein; specifically SEQ ID NO: 19 (S), 20 (S), 30 (S), 32 (MM) and 37 (Rep) (claims 3 and 4), with a pharmaceutically acceptable carrier in a nanosized emulsified preparation suitable for parenteral or mucosal application(s) (claim 3); the mimetic peptide has an overall length of from 6-50 amino acids (claim 3); the amino acid sequences being synthesized covalently to:
ii. A 7-aa spacer moiety;
wherein the mimetic peptide comprises a chemically synthesized amino acid, and/or a modified amino acid, and/or amino acid epitope that augments the immunogenicity of the S, MM and Rep amino acid sequences of part i;
wherein each amino acid sequence of S, MM and Rep is from about 6-10 amino acids, comprising a mixture of L- and D- enantiomers;
and
An immunogenic carrier coupled to the peptide; the carrier is selected from toxoidal proteins, among others (claim 5), such as TT (claim 6);
In claim 2, the immunogenic peptide further comprises 5 oligopeptides comprising elected species SEQ ID NO: 19, 20, 30, 32 and 37, and a pharmaceutically acceptable carrier.
The pharmaceutically acceptable carrier comprises an emulsion of an aqueous phase in which the immunogen is dissolved or in suspension, and an oily phase (claim 8). The oily phase comprises squalene, among others (claim 9), or at least one or more emulsifier agents (claim 10). The aqueous phase or the oily phase comprises at least one or more adjuvants (claim 11), such as QS-21, among others (claim 12), or uric acid, among others (claim 13).
Claim 7 is directed to an immunogenic composition comprising a therapeutically effective amount of the composition of claim 1 and a pharmaceutically acceptable carrier.
Also claimed is a method of immunization comprising administering to a patient having any beta-coronavirus infection the immunogenic composition (claim 14).
Claims 30-32, 34 and 37
Claim 30 is directed to a vaccine composition comprising 5 peptides: SEQ ID NO: 19 (S), 20 (S), 30 (S), 32 (MM) and 37 (Rep) (also encompassed by claims 34 and 37). The peptides are further coupled to an immunogenic carrier (claim 31). The vaccine composition further comprises an adjuvant, excipient, and/or pharmaceutically acceptable carrier (claim 32).
Sequences with 7-aa spacers
As outlined on pages 34-35 of the specification:
SEQ ID NO: 19 (Spacer-Spike) CppppSS-RSFIED; RSFIED is amino acids 815-820 of NCBI Reference Sequence: YP_009724390.1
SEQ ID NO: 20 (Spacer-Spike) CppppTT-STALGKLQD; STALGKLQD is amino acids 924-950 of NCBI Reference Sequence: YP_009724390.1, differing by residues ST underscored above.
SEQ ID NO: 30 (Spike-Spacer) QELIANQFNSA-SSppppC; QELIANQFNSA is amino acids 920-950 of NCBI Reference Sequence: YP_009724390.1, differing by residue E underscored above.
SEQ ID NO: 32 (Membrane-Spacer) NGTITVEELKKLLEQWN-TTppppC; NGTITVEELKKLLEQWN is amino acids 5-21 of Uniprot-listed P0DTC5.
SEQ ID NO: 37 (Replicase-Spacer) NLNRGM*VLGSLA-STppppC; NLNRGM*VLGSLA is amino acids 4236-4247 of Uniprot-listed P0DTC1, differing by residue M* underscored above.
Capital letters are L-isomers; lower case letters are D-isomers
M* is L-Norleucine (nLeu) the L-amino acid mimic for L-Methionine)
Claim Objections
Claims 3 and 14 are objected to because of the following informalities:
Claim 3, lines 5-6 recite “a pharmaceutically combination” [emphasis added].
Claim 14, line 1 recites “administering to patient”, which is missing an article.
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 1-14, 30-32, 34 and 37 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.
Claim 1 recites “at least one amino acid sequence conserved among beta coronaviruses”. The term “conserved” in claim 1 is a relative term which renders the claim indefinite. The term “conserved” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. Further, the specification does not indicate which beta coronaviruses the sequence is conserved among. Therefore, the metes and bounds of the claims cannot be determined.
Claim 1, lines 7-8, recite the limitation "the polypeptide immunogen". There is insufficient antecedent basis for this limitation in the former part of the claim. It appears that the conserved sequence of part (A)(i) may be the polypeptide immunogen since it comprises an immunogen(s).
Claim 4 recites, “the immunogen(s)”, which does not have antecedent basis in claim 1.
Claim 7 recites, “the polypeptide immunogenic composition”, which does not have antecedent basis in claim 1.
Claim 8 recites, “said pharmaceutically acceptable carrier according to claim 1”, which does not have antecedent basis in claim 1. Claim 8 also recites, “said immunogen”, which does not have antecedent basis in claim 1.
Claim 13 contains the trademark/trade name Ergamisol. Where a trademark or trade name is used in a claim as a limitation to identify or describe a particular material or product, the claim does not comply with the requirements of 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph. See Ex parte Simpson, 218 USPQ 1020 (Bd. App. 1982). The claim scope is uncertain since the trademark or trade name cannot be used properly to identify any particular material or product. A trademark or trade name is used to identify a source of goods, and not the goods themselves. Thus, a trademark or trade name does not identify or describe the goods associated with the trademark or trade name. In the present case, the trademark/trade name is used to identify/describe levamisole and, accordingly, the identification/description is indefinite.
Claims 30-32, 34 and 37 are directed to vaccines comprising SEQ ID NO: 19, 20, 30, 32 and 37. The claims do not recite what the vaccine is directed against, e.g., a vaccine against SARS-CoV-2. Without an indication of what the vaccine is against, the scope of the claims cannot be determined. Given that a vaccine is understood to be protective against disease, it is necessary to know what disease is being protected against in order to evaluate the metes and bounds of the claims.
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.
Claim 1 and 5-14 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. The claim(s) contains 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 inventor(s), at the time the application was filed, had possession of the claimed invention.
To provide adequate written description and evidence of possession of a claimed genus, the specification must provide sufficient distinguishing identifying characteristics of the genus. The factors to be considered include disclosure of complete or partial structure, physical and/or chemical properties, functional characteristics, structure/function correlation, methods of making the claimed product, or any combination thereof.
The claims are directed to a large genus of mimetic peptides having augmented immunogenicity. The structure provided in the claims for the mimetic peptides is that they are comprised of amino acid sequences from S, M and Rep synthesized covalently to a 7-aa spacer moiety and coupled to an immunogenic carrier. The mimetic peptides comprise a chemically synthesized amino acid, and/or modified amino acid, and/or amino acid epitope that augments the immunogenicity of the S, M and Rep sequences. The amino acid sequences comprise a mixture of L- and D- enantiomeric amino acids. The function provided in the claims is augmented immunogenicity.
The specification provides two examples of amino acids that augment immunogenicity, nPhe/F* and nLeu/M* (see paragraph [0112]). These two structures appear to be the only species of amino acids that have the required function of augmenting immunogenicity. Without further structure-correlation, one would not be in possession of the genus of amino acids that augment immunogenicity. These two species are not representative of the broad genus in claim 1 that does not specify any particular amino acid for augmenting immunogenicity. It is noted that of the elected species, only SEQ ID NO: 37 has nLeu/M*.
The specification provides 7-aa spacer peptides comprising combinations of the hydroxy amino acids S and T, with 4 prolines as D-enantiomers and a C residue at the N- or C- terminus (see paragraph [0013]). No other examples of spacer peptides are provided. This species of 7-aa spacer is not representative of the broad genus of 7-aa spacers recited in claim 1 which do not name any particular amino acids or motifs.
Accordingly, in the absence of sufficient recitation of distinguishing identifying characteristics, the specification does not provide adequate written description of the claimed genus. Amendment of the claims to recite the particular spacer moieties and the amino acids that augment immunogenicity would overcome this rejection.
Conclusion
No claim is allowed.
The combination of mimetic peptides comprising SEQ ID NO: 19, 20, 30, 32 and 37 is free of the prior art of record.
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Any inquiry concerning this communication or earlier communications from the examiner should be directed to Stacy B. Chen whose telephone number is 571-272-0896. The examiner can normally be reached on M-F (7:00-4:30). If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Thomas 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.
/STACY B CHEN/Primary Examiner, Art Unit 1671