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 Group I, claims 1-4, 6 and 24 in the reply filed on January 9, 2026 is acknowledged. Claims 13-15, 17, 19-23, 25, 27, and 29-31 are withdrawn as being drawn to non-elected invention.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on September 13, 2023, April 8, 2024, February 6, 2025, August 28, 2025, September 12, 2025 and November 14, 2025 have been considered by the examiner.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1, 4 and 6 are rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. The claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more.
The present claims are drawn 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 below:(a) the amino acid sequence selected from the group consisting of SEQ ID NOs: 1, 2, 3, 4, 5, 7,9,10, 11, 12, 13 and 15; and (b) the amino acid sequence in which one, two or several amino acids are substituted, deleted, inserted and/or added to the amino acid sequence selected from the group consisting of SEQ ID NOs: 1, 2, 3, 4, 5, 7, 9, 10, 11, 12, 13 and 15.
The claims are interpreted to recite a Markush group with regard to a) and b), and are thus interpreted to not require both (a) and (b) but either (a) or (b). Thus, the claims are drawn to peptides of SEQ ID NOs: 1, 2, 3, 4, 5, 7,9,10, 11, 12, 13 and 15.
The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the claimed SEQ ID NOs: 1, 2, 3, 4, 5, 7, 9, 10, 11, 12, 13 and 15 represent naturally occurring CTL peptide epitopes of SARS-CoV-2.
Gaynor et al. (US Patent Application Publication US 2023/0083931) disclose SARS-CoV-2 peptides of less than 15 amino acids in length identical with present SEQ ID NO: 2 and SEQ ID NO: 3 (see sequence alignments below).
Present SEQ ID NO: 2 and SEQ ID NO: 3408 in Gaynor et al.
Query Match 100.0%; Score 50; Length 10;
Best Local Similarity 100.0%;
Matches 10; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1 TAYANSVFNI 10
||||||||||
Db 1 TAYANSVFNI 10
Present SEQ ID NO: 3 and SEQ ID NO: 9052 in Gaynor et al.
Query Match 100.0%; Score 53; Length 9;
Best Local Similarity 100.0%;
Matches 9; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1 VFMSEAKCW 9
|||||||||
Db 1 VFMSEAKCW 9
DeGroot et al. (US Patent Application Publication US 2023/0190915) discloses SARC-CoV-2 CTL epitopes identical with present SEQ ID NO: 1 having the total length of 10 amino acids.
Present SEQ ID NO: 1 and SEQ ID NO: 7221 in DeGroot
Query Match 100.0%; Score 45; Length 10;
Best Local Similarity 100.0%;
Matches 9; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1 AYANSVFNI 9
|||||||||
Db 1 AYANSVFNI 9
Csiszowszki et al. (US Patent 10,973,909) discloses SARC-CoV-2 CTL epitopes identical with present SEQ ID NO: 5 having the total length of 15 amino acids.
Present SEQ ID NO: 5 and SEQ ID NO: 52
Query Match 100.0%; Score 54; Length 15;
Best Local Similarity 100.0%;
Matches 10; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1 PFAMQMAYRF 10
||||||||||
Db 5 PFAMQMAYRF 14
Perera et al. (US Patent 11,414,700) discloses SARC-CoV-2 CTL epitopes identical with present SEQ ID NO: 15 having the total length of 15 amino acids.
Present SEQ ID NO: 15 and SEQ ID NO: 18
Query Match 100.0%; Score 55; Length 15;
Best Local Similarity 100.0%;
Matches 10; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1 YAYLRKHFSM 10
||||||||||
Db 3 YAYLRKHFSM 12
Thus, since the present claims fail to recite significantly more than the judicial exception, the claims are rejected as being drawn non-statutory subject matter.
Claim Rejections - 35 USC § 102
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)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1, 4, 6 and 24 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Gaynor et al. (US Patent Application Publication US 2023/0083931).
The present claims are drawn 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 below:(a) the amino acid sequence selected from the group consisting of SEQ ID NOs: 1, 2, 3, 4, 5, 7,9,10, 11, 12, 13 and 15; and (b) the amino acid sequence in which one, two or several amino acids are substituted, deleted, inserted and/or added to the amino acid sequence selected from the group consisting of SEQ ID NOs: 1, 2,3,4,5,7, 9, 10, 11, 12, 13 and 15.
The claims are interpreted to recite a Markush group with regard to a) and b), and are thus interpreted to not require both (a) and (b) but either (a) or (b).
To require both (a) and (b) Applicant is suggested to recite: “which comprises the amino acid sequence comprising (a) and (b)”.
Gaynor et al. disclose peptides of less than 15 amino acids in length identical with present SEQ ID NO: 2 and SEQ ID NO: 3 (see sequence alignments below).
Regarding present claim 4. Gaynor et al. disclose an amino acid sequence consisting of a sequence identical with present SEQ ID NO: 2 and SEQ ID NO: 3. The sequences in Gaynor are 10 and 9 amino acids in length, respectively.
Regarding present claim 24. Gaynor et al. disclose kits comprising CTL epitopes (see paragraph [1275]).
Present SEQ ID NO: 2 and SEQ ID NO: 3408 in Gaynor et al.
Query Match 100.0%; Score 50; Length 10;
Best Local Similarity 100.0%;
Matches 10; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1 TAYANSVFNI 10
||||||||||
Db 1 TAYANSVFNI 10
Present SEQ ID NO: 3 and SEQ ID NO: 9052 in Gaynor et al.
Query Match 100.0%; Score 53; Length 9;
Best Local Similarity 100.0%;
Matches 9; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1 VFMSEAKCW 9
|||||||||
Db 1 VFMSEAKCW 9
Thus, by this disclosure Gaynor et al. anticipates the present claims.
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.
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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.
Claims 1-4, 6 and 24 are rejected under 35 U.S.C. 103 as being unpatentable over Gaynor et al. (US Patent Application Publication US 2023/0083931) in view of Dionne et al. (Cancer Immunological Therapy, 2004, Vol. 53, p. 307-314).
Gaynor et al. teach peptides of less than 15 amino acids in length identical with present SEQ ID NO: 2 and SEQ ID NO: 3 (see sequence alignment below).
Present SEQ ID NO: 2 and SEQ ID NO: 3408 in Gaynor et al.
Query Match 100.0%; Score 50; Length 10;
Best Local Similarity 100.0%;
Matches 10; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1 TAYANSVFNI 10
||||||||||
Db 1 TAYANSVFNI 10
Present SEQ ID NO: 3 and SEQ ID NO: 9052 in Gaynor et al.
Query Match 100.0%; Score 53; Length 9;
Best Local Similarity 100.0%;
Matches 9; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1 VFMSEAKCW 9
|||||||||
Db 1 VFMSEAKCW 9
Regarding present claim 6. Gaynor et al. teach a composition comprising two peptides identical with present SEQ ID NO: 2 and SEQ ID NO: 3 (see sequence alignment below and
Regarding present claim 24. Gaynor et al. disclose kits comprising CTL epitopes (see paragraph [1275]).
Regarding present claims 1-3. Gaynor et al. does not teach (a) the second amino acid from the N terminus is substituted with an amino acid selected from the group consisting of phenylalanine, tyrosine, methionine and tryptophan; and (b) the C-terminal amino acid is substituted with an amino acid selected from the group consisting of phenylalanine, leucine, isoleucine, tryptophan and methionine or (a) the second amino acid from the N terminus is substituted with an amino acid selected from the group consisting of leucine and methionine and (b) the C-terminal amino acid is substituted with an amino acid selected from the group consisting of valine and leucine.
Dionne et al., teach making amino acid substitutions within the anchor residues of the CTL epitopes, at the second position from the N terminus and at the C-terminal amino acid in order to make the CTL epitopes stronger peptide immunogens than the natural wild-type CTL epitopes (see Materials and Methods, Table 1 and Discussion).
It would have been prima facie obvious to provide the Gaynor’s CTL peptide epitopes identical with present SEQ ID NO: 2 and SEQ ID NO: 3 and to introduce amino acid substitutions within Gaynor’s CTL peptide epitopes because Dionne et al., teach making amino acid substitutions within the anchor residues of the CTL epitopes, at the second position from the N terminus and at the C-terminal amino acid, in order to make the CTL epitopes stronger peptide immunogens than the natural wild-type CTL epitopes (see Materials and Methods, Table 1 and Discussion). One would have been motivated to modify the CTL epitopes of Gaynor as suggested by Dionne in order to strengthen the peptide’s affinity to the HLA-A molecules and thereby increase the peptides immunogenicity (see Dionne page 312 right column).
Thus, the present invention would have been prima facie obvious at the time the invention was made.
Double Patenting
A rejection based on double patenting of the “same invention” type finds its support in the language of 35 U.S.C. 101 which states that “whoever invents or discovers any new and useful process... may obtain a patent therefor...” (Emphasis added). Thus, the term “same invention,” in this context, means an invention drawn to identical subject matter. See Miller v. Eagle Mfg. Co., 151 U.S. 186 (1894); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Ockert, 245 F.2d 467, 114 USPQ 330 (CCPA 1957).
A statutory type (35 U.S.C. 101) double patenting rejection can be overcome by canceling or amending the claims that are directed to the same invention so they are no longer coextensive in scope. The filing of a terminal disclaimer cannot overcome a double patenting rejection based upon 35 U.S.C. 101.
Claim 1-4, 6 and 24 are provisionally rejected under 35 U.S.C. 101 as claiming the same invention as that of claims 1-5 of copending Application No. 18/270,590. This is a provisional statutory double patenting rejection since the claims directed to the same invention have not in fact been patented.
The present claims are drawn 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 below:(a) the amino acid sequence selected from the group consisting of SEQ ID NOs: 1, 2, 3, 4, 5, 7,9,10, 11, 12, 13 and 15; and (b) the amino acid sequence in which one, two or several amino acids are substituted, deleted, inserted and/or added to the amino acid sequence selected from the group consisting of SEQ ID NOs: 1, 2,3,4,5,7, 9, 10, 11, 12, 13 and 15.
Claim 1 of copending Application No. 18/270,590 is drawn 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 below:(a) the amino acid sequence selected from the group consisting of SEQ ID NOs: 1, 2, 3, 4, 5, 7,9, 10, 11, 12, 13, 14 and 15; and (b) the amino acid sequence in which one, two or several amino acids are substituted, deleted, inserted and/or added to the amino acid sequence selected from the group consisting of SEQ ID NOs: 1, 2, 3, 4, 5, 7, 9, 10, 11, 12, 13, 14 and 15.
The present claims are drawn to the same invention as claims 1-5 of the copending application. Thus, the claims are provisionally rejected under 35 U.S.C. 101 as claiming the same invention.
Pertinent references
DeGroot et al. (US Patent Application Publication US 2023/0190915) discloses SARC-CoV-2 CTL epitopes identical with present SEQ ID NO: 1 having the total length of 10 amino acids.
Present SEQ ID NO: 1 and SEQ ID NO: 7221 in DeGroot
Query Match 100.0%; Score 45; Length 10;
Best Local Similarity 100.0%;
Matches 9; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1 AYANSVFNI 9
|||||||||
Db 1 AYANSVFNI 9
Csiszowszki et al. (US Patent 10,973,909) discloses SARC-CoV-2 CTL epitopes identical with present SEQ ID NO: 5 having the total length of 15 amino acids.
Present SEQ ID NO: 5 and SEQ ID NO: 52
Query Match 100.0%; Score 54; Length 15;
Best Local Similarity 100.0%;
Matches 10; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1 PFAMQMAYRF 10
||||||||||
Db 5 PFAMQMAYRF 14
Perera et al. (US Patent 11,414,700) discloses SARC-CoV-2 CTL epitopes identical with present SEQ ID NO: 15 having the total length of 15 amino acids.
Present SEQ ID NO: 15 and SEQ ID NO: 18
Query Match 100.0%; Score 55; Length 15;
Best Local Similarity 100.0%;
Matches 10; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1 YAYLRKHFSM 10
||||||||||
Db 3 YAYLRKHFSM 12
Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to AGNIESZKA BOESEN whose telephone number is (571)272-8035. The examiner can normally be reached on 8:30 - 5:00 PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Thomas Visone can be reached on 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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/AGNIESZKA BOESEN/Primary Examiner, Art Unit 1648