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 of Group 1 (a recombinant polypeptide, claims 1-11) and the species of SEQ ID NOs: 1, 9, and 18 as first, second, and third epitopes, respectively, in the reply filed on 2 Feb 2026 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Claims 12-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected inventions, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 2 Feb 2026.
Upon search and consideration, the combination of SEQ ID NOs: 1, 9, and 18 was found allowable and the search was expanded to the series of epitopes comprising SEQ ID NOs: 8, 9, and 18 as first, second, and third epitopes, respectively. In view of the withdrawal of the restriction requirement as to the rejoined inventions, applicant(s) are advised that if any claim presented in a divisional application is anticipated by, or includes all the limitations of, a claim that is allowable in the present application, such claim may be subject to provisional statutory and/or nonstatutory double patenting rejections over the claims of the instant application. Once the restriction requirement is withdrawn, the provisions of 35 U.S.C. 121 are no longer applicable. See In re Ziegler, 443 F.2d 1211, 1215, 170 USPQ 129, 131-32 (CCPA 1971). See also MPEP § 804.01.
Claim Status
The amended claim set filed 2 Feb 2026 is acknowledged. Claims 1-20 are currently pending. Of those all claims are original. Claims 12-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected inventions, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 2 Feb 2026. No claims are cancelled. Claims 1-11 will be examined on the merits herein.
The specification does not use paragraph numbers. To ensure that references to the specification are unambiguous across versions of the specification, this action will refer to paragraph numbers from the Pre-Grant Publication US-20230080865-A1.
Priority
The instant application claims priority to provisional application 63/243,317 (filed 13 Sep 2021). What follows is the examiner’s claim-by-claim analysis of effective filing date for the claims currently under examination. If the applicant disagrees with this examiner’s determination of effective filing date for any claim, the applicant may identify text within the prior applications that provides support the claimed language.
Regarding claim 1 and its dependent claims, ‘317 provides support for “a polypeptide including a series of epitopes (SOE) which includes at least a plurality of epitopes, said epitopes being arranged as a linear chimeric array protein comprised of at least 8 non-unique, immunogenic epitopes of epitopes of fructose-1, 6-bisphosphate aldolase (A), at least 9 non-unique, immunogenic epitopes of α-enolase (E) and at least 12 non-unique, immunogenic epitopes of glyceraldehyde-3-phosphate dehydrogenase (G), with each of said epitopes being connected by an amino acid linker” (for example, ‘317 claim 1, emphasis added). What is currently claimed is broader and includes SOEs with as few as one immunogenic epitope from each of the proteins (see Table 1 in the instant specification to map the sequences to the protein names). Therefore, the scope of proteins claimed is not fully supported in the provisional application.
Regarding claim 10, this protein is limited to the protein comprising SEQ ID NO: 30, which is AEG::SOE3 [instant 0011]. This protein is fully supported in the provisional application, for example see [‘317 0001].
Therefore, the effective filing date used for searching claims 1-9 and 11 is 13 Sep 2022, but the effective filing date used for searching claim 10 is 13 Sep 2021.
Nucleotide and/or Amino Acid Sequence Disclosures
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 - This application contains sequence disclosures in accordance with the definitions for nucleotide and/or amino acid sequences set forth in 37 CFR 1.821(a)(1) and (a)(2). However, this application fails to comply with the requirements of 37 CFR 1.821 - 1.825.
The sequence disclosures are located in Table 1; the sequence IGTSHGAYKFPPGTK, labeled SEQ ID NO: 8, does not correspond with the SEQ ID NO: 8 in the sequence listing. This sequence is not present in the sequence listing, so there was not a typographical error in the sequence identifier in the specification.
Required response – Applicant must provide:
A "Sequence Listing" part of the disclosure, as described above in item 1); as well as
An amendment specifically directing entry of the "Sequence Listing" part of the disclosure into the application in accordance with 1.825(b)(2);
A statement that the "Sequence Listing" includes no new matter in accordance with 1.825(b)(5); and
A statement that indicates support for the amendment in the application, as filed, as required by 37 CFR 1.825(b)(4).
If the "Sequence Listing" part of the disclosure is submitted according to item 1) a) or b) above, Applicant must also 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 copy of the previously-submitted specification, with deletions shown with strikethrough or brackets and insertions shown with underlining (marked-up version);
A copy of the amended specification without markings (clean version); and
A statement that the substitute specification contains no new matter;
If the "Sequence Listing" part of the disclosure is submitted according to item 1) b), c), or d) above, Applicant must also provide:
A replacement CRF in accordance with 1.825(b)(6); and
Statement according to item 2) a) or b) above.
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 incorporation by reference paragraph is improper because it does not include the size of the ASCII text file in bytes as required. For applicant’s convenience, the Office’s understanding of the file size is below:
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46
414
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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 copy of the previously-submitted specification, with deletions shown with strikethrough or brackets and insertions shown with underlining (marked-up version);
A copy of the amended specification without markings (clean version); and
A statement that the substitute specification contains no new matter.
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.
Claims 1-11 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.
Regarding claim 1, the claim recites “wherein each of said epitopes”. There is insufficient antecedent basis for this limitation in the claim because it is not clear whether “said epitopes” refers to the series of epitopes as a whole, or to the first, second, or third epitopes. In the interest of compact prosecution, the claim has been examined with “said epitopes” having antecedent basis to the series of epitopes as a whole (i.e. first, second, and third epitopes). As a suggestion, applicant may wish to change the terms “first, second, or third epitopes” to use a term such as “first, second, or third sequences” instead, so one can unambiguously determine when the claims refer to the SOE as a whole compared to the parts within it.
Also regarding claim 1, the claim recites that the first epitope can be “SEQ ID NO: 8”. The instant specification at Table 1 (following [0060]) states: “IGTSHGAYKFPPGTK (SEQ ID NO: 8)”. However, the sequence listing states that SEQ ID NO: 8 is “MEQLQAIITASVKTESEEVSAGARKYANQTMLRYMAQEELIPIVLHLDHGDSFEEEYAHSRPDYVTVEGELEEIGTSHGAYKFPPGTKEESSSIPQEYVEMVNKYEEDGRMVMTGTIRRLFVEEAEHDAIVKECIAEAAEELRDGDKARYGGKGTQEEILNGGKHAGGNLKFQEEPFPDQQLRMVAEVYQKEELLKKHPAIVSIEDALAELDYENWTKLGLVGDDLYTTNPITIKGARGERIQKYTRLLQIYDYLKEHDMLAEEEEGRLGPSQLPWKELGIEEGYDGHLVSGAKKWLEEETKCISNASCTTNCLEEKDLRARAAGMNIIPTSTGAAIA LPKVCHGLPPKSLDEETGSLVVNVNAKVEEDPIVSSDIIGCQYSSIVDALSTKVLPNPEELVKVLSWYDNEWMYSCRCADFHRLEKYLEEHHHHHH”. Therefore, claim 1 is indefinite because the two different definitions of the term “SEQ ID NO: 8” makes it unclear which sequence is claimed. Claims 2-11 are also rejected because they depend from claim 1 and do not obviate this grounds of rejection.
Regarding claim 2, the claim recites “the peptide linkers joining the first, second and third epitopes”. There is insufficient antecedent basis for this limitation in the claim. As there may be “at least one” first, second and third epitopes, it is not clear whether the linkers are those that join the epitopes within groups (e.g. joining SEQ ID NOs: 1-8 together) or whether the linkers are those that join the epitopes between groups (e.g. joining first epitope(s) to second epitope(s)). In the interest of compact prosecution, the claim has been examined with this limitation applying to all linkers between all epitopes in the protein, both those within and between groups.
Regarding claims 2 and 6-8, the instant specification states “unless otherwise indicated, numbers expressing quantities of ingredients, constituents, reaction conditions and so forth used in the specification and claims are to be understood as being modified by the term “about.”” [0029]. These claims contain numbers, but it is unclear whether or not amino acid length and numbers of epitopes fall into the category of “quantities of ingredients, constituents”. Therefore, the scope is indefinite because it is unclear whether these claims should be interpreted as exact numbers or as if the numbers were modified by the term “about.”
Regarding claim 9, the claim recites “the isoelectric point of the SOE is in a range from about 4.90 to about 5.10.” The claim recites many different SOEs comprising different combinations of one or more first, second, and third epitopes. However, the isoelectric point can change if the order of the epitopes is changed or one of the epitopes is added or removed. Therefore, the claim is indefinite because one of ordinary skill in the art at the time of filing would not be able to determine which SOE(s) fall within the claimed range.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to AMELIA N DICKENS whose telephone number is (571)272-0381. The examiner can normally be reached M-F 8:30-4:30 (EDT/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, Samira Jean-Louis can be reached at (571) 270-3503. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/AMELIA NICOLE DICKENS/Examiner, Art Unit 1645
/SAMIRA J JEAN-LOUIS/Supervisory Patent Examiner, Art Unit 1642
Prosecution Insights