DETAILED ACTION
Notice of Pre-AIA or AIA Status
1. 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
2. Applicant's election with traverse of Group I (claims 1-10, 19-20, and 29) and SEQ ID NOs: 6, 12 and 19 for the B cell epitope, Th epitope, and peptide, respectively, in the reply filed on 19 May 2026 is acknowledged. It is noted that SEQ ID NO: 12 reads on the election of a tetanus toxoid Th epitope. The traversal is on the grounds that Groups I and II share a common technical feature that makes contribution over the prior art and that the groups fall under 37 CFR § 1.475(b)(2). Applicant further argues that the present species represent a reasonably finite number of species. This is not found persuasive because the presence of any particular invention categories does not remove the requirement for a special technical feature. As discussed in the Requirement for Restriction/Election mailed 19 March 2026 on pages 4-5, the common technical feature does not provide a contribution over the prior art. Furthermore, Applicant does not state what common technical feature between Groups I and II allegedly makes contribution over the prior art. Regarding 37 CFR § 1.141, the species claims must be dependent on an allowable generic claim or otherwise include all the limitations of the generic claim. None of the claims are generic, nor do they possess a special technical feature that makes a contribution over the prior art. Thus, the requirement is still deemed proper and is therefore made FINAL.
Claims 3-5, 10, 19-20, 29, and 35-41 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to the nonelected group and species, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 19 May 2026.
Claim Status
3. Claims 11-18, 21-28, 30-34, and 42 are canceled.
Claims 3-5, 10, 19-20, 29, and 35-41 are withdrawn.
Claims 1-2, and 6-9 are under consideration.
Priority
4. The Instant Application is a National Stage (371) of PCT/US2022/027482, filed 03 May 2022, which claims prior to U.S. Provisional Application 63/183,222, filed 03 May 2021. The species election of SEQ ID NOs: 6, 12, and 19 are all disclosed in 63/183,222 and thus the instant claims are granted the effective filing date of 03 May 2021.
Information Disclosure Statement
5. The information disclosure statements (IDS) submitted on 12 May 2025 and 03 November 2023 were filed before the mailing date of the Non-Final Office Action. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
6. The listing of references in the specification is not a proper information disclosure statement. 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609.04(a) states, "the list may not be incorporated into the specification but must be submitted in a separate paper." Therefore, unless the references have been cited by the examiner on form PTO-892, they have not been considered.
Drawings
7. The drawings are objected to because the drawing in figure 2 is indiscernible. Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Specification
8. Applicant is reminded of the proper language and format for an abstract of the disclosure.
The abstract should be in narrative form and generally limited to a single paragraph on a separate sheet within the range of 50 to 150 words in length. The abstract should describe the disclosure sufficiently to assist readers in deciding whether there is a need for consulting the full patent text for details.
The language should be clear and concise and should not repeat information given in the title. It should avoid using phrases which can be implied, such as, “The disclosure concerns,” “The disclosure defined by this invention,” “The disclosure describes,” etc. In addition, the form and legal phraseology often used in patent claims, such as “means” and “said,” should be avoided.
Claim Objections
9. Claims 1 and 9 are objected to because of the following informalities:
Regarding claim 1, a colon should be added after “the group consisting of”.
Regarding claim 9, “chimeric” should be added before “peptide comprises” for consistency. Appropriate correction is required.
Claim Interpretation
10. Examiner is interpreting the language of “consist of a sequence selected from the group consisting of” of claim 1 to require the full sequence and nothing more.
Claim Rejections - 35 USC § 112(b)
11. 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.
12. Claim 6 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.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 6 recites the broad recitation “tetanus toxoid”, and the claim also recites “(TT3)” which is the narrower statement of the range/limitation since there are multiple tetanus toxoid peptides. The claim is considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims. Examiner is interpreting the recitation of “(TT3)” to be exemplary and thus the claim only requires any tetanus toxoid peptide.
Claim Rejections – Improper Markush
13. Claims 1 and 6-9 are rejected on the basis that they contain an improper Markush grouping of alternatives. See In re Harnisch, 631 F.2d 716, 721-22 (CCPA 1980) and Ex parte Hozumi, 3 USPQ2d 1059, 1060 (Bd. Pat. App. & Int. 1984). A Markush grouping is proper if the alternatives defined by the Markush group (i.e., alternatives from which a selection is to be made in the context of a combination or process, or alternative chemical compounds as a whole) share a “single structural similarity” and a common use. A Markush grouping meets these requirements in two situations. First, a Markush grouping is proper if the alternatives are all members of the same recognized physical or chemical class or the same art-recognized class, and are disclosed in the specification or known in the art to be functionally equivalent and have a common use. Second, where a Markush grouping describes alternative chemical compounds, whether by words or chemical formulas, and the alternatives do not belong to a recognized class as set forth above, the members of the Markush grouping may be considered to share a “single structural similarity” and common use where the alternatives share both a substantial structural feature and a common use that flows from the substantial structural feature. See MPEP § 2117.
The Markush grouping of claims 1 and 9 are improper because the alternatives defined by the Markush grouping do not share both a single structural similarity and a common use for the following reasons: SEQ ID NOs: 1-10 do not share a common core structure of a consensus sequence. SEQ ID NOs: 14-23 are the full chimeric peptide, which comprise SEQ ID NOs: 1-10 that will be responsible for the specific immune response. The common use of all the peptides is to stimulate an anti-coronavirus immune response. The only structural features that will provide this functionality are the B cell epitopes, which vary in sequence and thus do not sure a common structure that yields the common use. Claims 6-9, which depend on claim 1, are similarly rejected.
To overcome this rejection, Applicant may set forth each alternative (or grouping of patentably indistinct alternatives) within an improper Markush grouping in a series of independent or dependent claims and/or present convincing arguments that the group members recited in the alternative within a single claim in fact share a single structural similarity as well as a common use.
Claim Rejections - 35 USC § 103
14. 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.
15. 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.
16. Claim 1 is rejected under 35 U.S.C. 103 as being unpatentable over Sathyanarayanan (US 20250114445 A1; priority to 20 March 2020) in view of Ong (US 20240044895 A1; priority to 18 September 2020).
Regarding claim 1, Sathyanarayanan teaches an antigen with the following structure:
(B cell antigen)-(spacer)-(T helper peptide) (¶ [0209]), wherein the B cell antigen can be from a coronavirus, such as SARS-CoV-2 (¶ [0532]). Sathyanarayanan does not teach the specific sequence of the B cell antigen. However, Ong teaches a vaccine composition for eliciting an immune response in a subject against SARS-CoV-2 (¶ [0012]), wherein the vaccine comprises an adjuvant and a peptide having at least 90% similarity to one or more peptides that is an 18-mer or longer in Table 9A or 9B (¶ [0060]). It is noted that due to the poor visibility of Table 9A and 9B in the PGPub, Examiner used the corresponding table that was provided in the provisional for the pasted sequence below. Table 9A discloses the following peptide:
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, which corresponds with SEQ ID NO: 947 (‘Db’) of Ong. This sequence matches instant SEQ ID NO: 6 (‘Qy’) aside from one amino acid at the beginning:
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Table 9B discloses the following peptide:
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, which corresponds with SEQ ID NO: 1618 (‘Db’) of Ong. This sequence matches SEQ ID NO: 6 (‘Qy’) aside from two amino acids at the end:
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Therefore, it would have been obvious to one of ordinary skill before the time of filing to combine the two epitopes above to make one peptide carrying all residues thereof which is SEQ ID NO: 6 of the Instant Application. Since the epitopes above were taught to be used in a vaccine to elicit an immune response with the first amino acid or last two amino acids removed, combining them would predictably result in an epitope that can also elicit an immune response since all structural requirements are met by the composite sequence from the two peptides of Ong. It would further be obvious to use this epitope in the antigen of Sathyanarayanan. The combination of familiar elements is likely to be obvious when it does no more than yield predictable results. See KSR International Co. v. Teleflex Inc., 550 U.S. 398, 415-421, 82 USPQ2d 1385, 1395 – 97 (2007) (see MPEP § 2143, A.). A rationale to support a conclusion that a claim would have been obvious is that all the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination would have yielded nothing more than predictable results to one of ordinary skill in the art. See KSR International Co. v. Teleflex Inc., 550 U.S. 398, 415-421, 82 USPQ2d 1385, 1395 (2007) (see MPEP §§ 2143, A. and 2143.02).
17. Claim 2 is rejected under 35 U.S.C. 103 as being unpatentable over Sathyanarayanan (Supra) and Ong (Supra) as applied to claim 1 above, and further in view of Zhao (29 November 2016, AMB Express, 6(122)).
Regarding claim 2, Sathyanarayanan and Ong teach all the limitations of claim 1, as discussed supra. All discussions thereon incorporation here. Neither reference teaches that the amino acids of the SARS-CoV-2 B cell epitope are the D-enantiomer. However, Zhao teaches that “In nature, almost all of the proteins and peptides were composed of L-amino acid. Different enzyme could recognize specific peptide bond formed by L-amino acid and break it… However, enzyme could not break the peptide bond formed by D-amino acid for the difference of the spatial configuration. Actually, there is no difference between L-amino acid and its D-counterpart in the chemical and physical property. So, D-amino
acid substitution almost has no influence on the chemical and physical property of the peptides except the configuration.” (Page 8, ¶ 2).
Therefore, it would have been obvious to one of ordinary skill before the effective filing date to make the SARS-CoV-2 B cell epitope more resistant to enzymatic degradation and thus increases its half-life. This is beneficial as it allows the epitopes to circulate in the immune system for a longer period of time, resulting in a stronger immune response. A rationale to support a conclusion that a claim would have been obvious is that there is some teaching, suggestion, or motivation in the prior art or in the knowledge generally available to one of ordinary skill in the art to modify the reference or combine reference teachings, and the modification or combination would have a reasonable expectation of success. See KSR International Co. v. Teleflex Inc., 550 U.S. 398, 415-421, 82 USPQ2d 1385, 1395 (2007) (see MPEP §§ 2143, G. and 2143.02).
18. Claims 6-9 are rejected under 35 U.S.C. 103 as being unpatentable over Sathyanarayanan (Supra), Ong (Supra), and Zhao (Supra) as applied to claim 2 above, and further in view of Kaumaya (US 20050233964 A1; Published 20 October 2005).
Regarding claims 6-9, Sathyanarayanan and Ong teach all the limitations of claim 1, as discussed supra. All discussions thereon incorporation here. Sathyanarayanan further teaches that the T helper peptide can be derived from tetanus (¶ [0419]). Neither reference teaches the specific sequences for the linker, Th epitope, or the chimeric peptide. However, Kaumaya teaches compositions for stimulating the immune system (¶ [0007]) using chimeric VEGF peptides with a VEGF epitope, Th cell epitope, and a linker connecting the two (¶ [0013]-[0014]). The preferable Th epitope sequence is (¶ [0013]):
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Which corresponds with a clostridium tetani epitope, as shown on page 16:
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This SEQ ID NO: 6 (‘Db’) of Kaumaya has a 100% match to SEQ ID NO: 12 (‘Qy’) of the Instant Application:
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The preferable linker sequence is Gly-Pro-Ser-Leu (¶ [0014]), which is SEQ ID NO: 10 of Kaumaya (‘Db’) and has a 100% match to SEQ ID NO: 13 (‘Qy’) of the Instant Application:
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Therefore, it would have been obvious to one of ordinary skill in the art to take the antigen structure made obvious by Sathyanarayanan and Ong and further use the tetanus toxoid peptide and linker of Kaumaya in place of the T helper peptide and linker thereof, respectively. The structure of Sathyanarayanan with the SARS-CoV-2 epitope of Ong and the Th epitope and linker of Kaumaya makes SEQ ID NO: 19 obvious. The structures of Kaumaya meet the functional requirements of the obvious molecule, providing a Th epitope from tetanus and a linker sequence. Thus, their use in the obvious molecule would yield predictably a functional immune response-stimulating chimeric peptide. The combination of familiar elements is likely to be obvious when it does no more than yield predictable results. See KSR International Co. v. Teleflex Inc., 550 U.S. 398, 415-421, 82 USPQ2d 1385, 1395 – 97 (2007) (see MPEP § 2143, A.). A rationale to support a conclusion that a claim would have been obvious is that all the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination would have yielded nothing more than predictable results to one of ordinary skill in the art. See KSR International Co. v. Teleflex Inc., 550 U.S. 398, 415-421, 82 USPQ2d 1385, 1395 (2007) (see MPEP §§ 2143, A. and 2143.02).
Furthermore, Guo (05 October 2022, OncoImmunology, 11(1)) makes it evident that the tetanus epitope taught by Kaumaya is the tetanus toxoid (TT3): “tetanus toxoid (TT3), residue (947–967, FNNFTVSFWLRVPKVSASHL)” (Peptide synthesis).
Conclusion
19. No claim is allowed. Any inquiry concerning this communication or earlier communications from the examiner should be directed to KRISTINA E LY whose telephone number is (571)272-5169. The examiner can normally be reached Monday - Thursday, 8:00 am - 5:00 pm EST.
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/KRISTINA E. LY/Examiner, Art Unit 1671 /Michael Allen/Supervisory Patent Examiner, Art Unit 1671
Prosecution Insights