8Notice 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 .
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. The earliest possible effective filing date for the instant claims is 05/18/2021 based on the filing date of the provisional application 63190116.
Status of Claims
Claims 1-4, 9, 13, 21, 23 have been amended.
Claims 6-8, 11-12, 15-20, 26-33 are withdrawn.
Claims 1-5, 9-10, 13-14, and 21-25 are examined on their merits.
Information Disclosure Statement
The Information Disclosure Statements filed on 06/20/2022, 09/25/2025, and 12/13/2024 are acknowledged and have been considered.
Declaration Submission
The Declaration under 37 CFR 1.132 filed 9/25/2025 is insufficient to overcome the rejection of claims 1-5, 13, and 14 under 35 U.S.C. 101 because the claimed inventions are directed to a judicial exception without significantly more for the reasons as set forth below.
Drawings
(previous objection, withdrawn) The drawings are objected to because the drawings are indicated by “Figure” rather than “FIG.” as required by 37 C.F.R § 1.84 (u)(1) (see also MPEP § 608.02 (V)).
Applicant contends: the drawings are amended.
In view of applicant’s amendments, the objection is withdrawn.
Nucleotide and/or Amino Acid Sequence Disclosures
(previous objection, maintained)
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 - The Incorporation by Reference paragraph required by 37 CFR 1.821(c)(1) is missing or incomplete. See item 1) a) or 1) b) above.
Specifically, the ASCII file size is listed in KB (kilobytes) rather than bytes as required.
Required response – Applicant must provide:
A substitute specification in compliance with 37 CFR 1.52, 1.121(b)(3) and 1.125 inserting the required incorporation-by-reference paragraph, consisting of:
A statement that the substitute specification contains no new matter.
Applicant contends: the Nucleotide and/or Amino Acid Sequence Disclosures are amended.
While the applicant did resolve some of the issues, a statement that the substitute specification contains no new matter is still required. As a result, the objection is maintained.
Specification
(previous objection, maintained). The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code on page 36. 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. This can be achieved by replacing “dots” with underscores in the URL; for example, “www_” or “_com”. Please thoroughly check the specification for any other URLs beyond those listed above. See MPEP § 608.01.
Applicant contends: the Specification is amended with respect to embedded hyperlink and/or other form of browser-executable code .
While the applicant did resolve some of the issues, embedded hyperlink and/or other form of browser-executable code is still present. As a result, the objection is maintained.
Claim Objections
(new objection, necessitated by amendment) Claim 2 is objected to because of the following informalities:
Claim 2: Add “class I” after MHC. For example, MHC class I.
Appropriate correction is required.
Claim Rejections - 35 USC § 112(a)
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.
(previous rejection; withdrawn) Claims 1-5, 9-10, 13-14, and 21-25 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 claims contain 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. [Insufficient description of a representative number of species].
See claims 1-5, 9-10, 13-14, and 21-25 as submitted 09/25/2025.
Applicant contends: the claims have been amended.
In view of applicant’s amendments, the rejection is withdrawn.
(previous rejection; withdrawn) Claims 1-5, 9-10, 13-14, and 21-25 are additionally rejected under the written description requirement for reciting the limitations “binds to a molecule of a major histocompatibility complex (MHC)” (i.e., claims 1, 4, 9, 13, and 21) and “the peptide has the ability to bind to an MHC class-I or II molecule” (i.e., claim 2).
See claims 1-5, 9-10, 13-14, and 21-25 as submitted 09/25/2025.
Applicant contends: the claims have been amended.
In view of applicant’s amendments, the rejection is withdrawn.
(previous rejection; withdrawn) Claims 4 and 5 are additionally rejected under the written description requirement for reciting the limitation of an immunogenic composition comprising a peptide comprising an amino acid sequence selected from SEQ ID NOs 1-26.
See claims 4 and 5 as submitted 09/25/2025.
Applicant contends: the claims have been amended.
In view of applicant’s amendments, the rejection is withdrawn.
Claim Rejections - 35 USC § 112(b)
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.
(previously rejection; withdrawn) Claim 23 is 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.
See claim 23 as submitted 09/25/2025.
Applicant contends: the claims have been amended.
In view of applicant’s amendments, the rejection is withdrawn.
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.
(previous rejection; maintained) Claims 1-5, 13, and 14 are rejected under 35 U.S.C. 101 because the claimed inventions are directed to a judicial exception without significantly more. This judicial exception is not integrated into a practical application, and the claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception for the reasons set forth below. See MPEP § 2106 for patent subject matter eligibility analysis.
Claims 1-5, 13, and 14 as submitted 09/25/2025.
Applicant contends:
As set forth above, independent claim 1, as amended, recites:
1. (Currently amended) A peptide, consisting of an amino acid sequence selected from the group consisting of SEQ ID NO: 1 to SEQ ID NO: 26, and wherein the peptide has the
ability to bind to a molecule of a major histocompatibility complex (MHC) class I and/or
induce T cells cross-reacting with the peptide.
(Emphasis added.)
According to MPEP § 2111.03, the transitional phrase "consisting of' excludes any element, step, or ingredient not specified in the claim. Therefore, the peptide of the amended claim 1 has only 9-10 amino acids and excludes any amino acid not specified in the claim.
As explained in the CHANG Declaration, these peptides are structurally and
functionally distinct from any naturally occurring counterpart. They possess free amino and carboxyl termini, unlike peptides within proteins, which are joined continuously by peptide bonds. For example, SEQ ID NO: 22 exists with free termini, whereas its naturally occurring counterpart is constrained within a 354-amino acid protein disclosed by Varghese (CHANG Declaration 6-6.2).
Furthermore, MHC class I molecules bind only short peptides of 8-10 amino acids. The naturally occurring 354-amino acid protein of Varghese cannot be presented by MHC class I and therefore cannot induce CD8* T-cell responses. In contrast, as shown in Example 1 and FIG. 2, the claimed peptides bind strongly to HLA-A201, the most prevalent human MHC class I allele. Thus, these peptides are functionally capable of binding MHC class I molecules and inducing immune responses, unlike their naturally occurring counterparts (CHANG Declaration 6.3- 6.3.3).
In addition, amended claim 3 recites:
3. (Currently amended) A nucleic acid encoding the peptide consisting of an amino acid
sequence selected from the group consisting of SEQ ID NOs: 1-21 and 23-26 according
to claim 1.
Because peptides consisting of an amino acid sequence selected from the group
consisting of SEQ ID NOs: 1-21 and 23-26 do not occur in nature, nucleic acids encoding these peptides are likewise not naturally occurring. Therefore, the nucleic acid recited in claim 3 falls outside the scope of a judicial exception.
Accordingly, Applicant respectfully submits that claims 1-5, 13, and 14 are directed to patent eligible subject matter, not a naturally occurring product, and requests withdrawal of this rejection.
Accordingly, the claimed peptides are not natural products, but instead constitute patent-eligible subject matter under 35 U.S.C. §101. Applicant respectfully requests withdrawal of the § 101 rejection.
Response to Arguments:
Applicant’s amendments to the claims are acknowledged, specifically the increased precision of language with respect to use of “consisting” and clarifying the MHC binding ability of the peptides with the amino acid sequences of SEQ ID NO: 1-26 as well as the removal of the variant species. Additionally, the filed Declaration from Jia-Ming Chang is acknowledged as indicated above.
Using MPEP 2166 for patent subject matter eligibility analysis as before, amended claims 1-5, 13-14 meet the criteria for statutory categories of invention (STEP 1 -YES).
SEQ ID NO: 22 is still considered a fragment of a naturally occurring polypeptide as taught by Varghese (UniProt accession number A0A173MI34_9BACT deposited 2016- see attached form 892) as evidenced by GenBank accession number FTOR01000002.1 (deposited 2017(See previously submitted PTO-892 Reference cited).
Note: SEQ ID NOs 6, 12, and 21 are also considered fragments of a naturally occurring polypeptide as taught by Gilroy et al. (SEQ ID NO: 6)(See Result #1,A0ABR8U4R7_9BACL, of Search Result us-17-726-688-6.pct95.rup, 04/15/2026, see supplemental contents tab), De Vries et al. (SEQ ID NO: 12)(See Result #1,A0A1L9TQJ9_9EURO, of Search Result us-17-726-688-12.pct95.rup, 04/10/2026, see supplemental contents tab), and Zhang et al (SEQ ID NO: 21)(See Result #1, A0A834ZL27_TETSI, of Search Result us-17-726-688-21.pct95.rup, 04/10/2026, see supplemental contents tab (See PTO-892 Notice of References Cited).
As such, claims 1-5, 13, and 14 recite judicial exceptions in the form of a natural phenomenon/ product of nature (Step 2A, Prong 1- YES).
Amended claims 1-5, 13 and 14, do not recite additional elements that integrate this judicial exception into a practical application. The claimed peptides have a different structural characteristic than naturally occurring peptides within the polypeptide, because the claimed peptides have severed peptide bonds (as also mentioned in the Declaration submitted). However, the peptides do have the same amino acid sequences as the naturally occurring peptide fragments within the polypeptide. Therefore, the claimed peptide is different but not markedly different from its natural counterpart in its natural state and thus is a “product of nature” exception (see Example 7 of the Nature Based Products Examples/101 Guidance available at https://www.uspto.gov/sites/default/files/documents/mdc_examples_nature-based_products.pdf). With respect to the claim that the peptides can bind MHC class I molecules, the MPEP teaches a composition and its properties are inseparable (Under MPEP guidelines, a chemical compound and its properties are considered inseparable: "If a prior art reference discloses an identical structure, the properties claimed by the applicant are deemed inherent, making the claimed compound anticipated or obvious, even if the reference does not explicitly mention those properties”, per MPEP 2112.01).
Again, the pharmaceutically acceptable carrier as recited in claim 14 could be, for example, water.
As such, claims 1-5, 13, and 14 do not recite additional elements that integrate the judicial exception into a practical application (Step 2A, Prong 2- NO).
As detailed in the previous 35 U.S.C. 103 rejection, particularly with the teachings of Poluektov et al. and Matsui et al., it was well-understood, routine, and conventional before the effective filing date of the claimed invention to design peptides and use them in an immunogenic or pharmaceutical composition. As such, beyond the judicial exception, the instant claims only recite well-understood, routine, and conventional products. These products constitute insignificant extra-solution aspects, which do not reasonably provide an inventive concept. As such, the instant claims do not recite any additional elements that amount to significantly more than the judicial exception (Step 2B- NO).
Accordingly, claims 1-5, 13, and 14 do not constitute patent eligible subject matter under 35 U.S.C. 101.
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)(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.
(previous rejection; withdrawn) Claims 1 and 3 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by previously recited Varghese (UniProt accession number A0A173MI34_9BACT deposited 2016) as evidenced by previously recited GenBank accession number FTOR01000002.1.
See claims 1 and 3 as submitted 09/25/2025.
Applicant contends: the claims have been amended.
In view of applicant’s amendments, the rejection is withdrawn.
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 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.
(previous rejection; withdrawn) Claim 2 is rejected under 35 U.S.C. 103 as being unpatentable over Varghese and further in view of Poluektov et al (Vaccine 2021- included on IDS).
See claim 2 as submitted 09/25/2025.
Applicant contends: the claims have been amended.
In view of applicant’s amendments, the rejection is withdrawn.
(previous rejection; withdrawn) Claims 4, 5, 9, 10, 13 and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Varghese as evidenced by GenBank accession number FTOR01000002.1 and Matsui et al (US20110262529A1- included on IDS).
See claims 4, 5, 9, 10, 13 and 14 as submitted 09/25/2025.
Applicant contends: the claims have been amended.
In view of applicant’s amendments, the rejection is withdrawn.
Allowable Subject Matter
Claims 9-10, 21-25 are allowed.
Conclusion
THIS ACTION IS MADE FINAL. 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 Claire Cornelius whose telephone number is (571) 272-0860. The examiner can normally be reached M-F, 0930-1700.
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 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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/C.C./Examiner, Art Unit 1672
/M FRANCO G SALVOZA/Primary Examiner, Art Unit 1672
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