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 .
Information Disclosure Statement
2. The information disclosure statement (IDS) submitted on 02/27/26 was filed and entered. The submission is in compliance with the provisions of 37 CFR 1.97 and has been considered by the Examiner.
Declaration
3. The Declaration of Matthew P. Delisa under 37 CFR 1.130(a) filed 02/27/26 is sufficient to overcome the rejection of claims 1-18 based upon Weyant et al. 2021 (A Modular Platform for On-Demand Vaccine Self-Assembly Enabled by Decoration of Bacterial Outer Membrane Vesicles with Biotinylated Antigens; bioRxiv 2021).
Claim Status
4. The amendment, filed 02/27/26, has been entered. Claims 1-45 are pending. Claims 44-45 are newly added. Claims 1-7, 10-11, 19, 21-22, 24-25, and 28-29 are amended. Claims 19-43 have been withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 04/29/25. Claims 1-18 and 44-45 are under examination.
Withdrawal of Objections/Rejections
5. The following are withdrawn from the Office Action, filed 08/28/25:
The rejection of claims 1, 2, 5, and 6 under 35 U.S.C. 112(b) as being indefinite, found on page 3 at paragraph 7, is withdrawn in light of Applicant’s amendments thereto; however, see maintained rejection for claims 3, 4, 10 and 11 and new rejections for claims 1-6 (below).
The rejection of claims 4 and 11 under 35 U.S.C. 112(d), found on page 5 at paragraph 9, is withdrawn in light of Applicant’s amendments thereto.
The rejection of claims 1-18 under 35 U.S.C. 102(a)(1) as being anticipated by Weyant et al. 2021 (A Modular Platform for On-Demand Vaccine Self-Assembly Enabled by Decoration of Bacterial Outer Membrane Vesicles with Biotinylated Antigens; bioRxiv 2021), found on page 6 at paragraph 12, is withdrawn in light of Applicant’s amendments submission of a declaration to establish that Weyant is not available as prior art (i.e. not “by another”; see above).
Maintained Rejections: Claim Rejections - 35 USC § 112
6. 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.
7. Claims 3, 4, 10 and 11 are rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention.
Claim 3 and claim 10 are each indefinite because of the use of parentheses. Although parenthesis may be appropriate when defining an abbreviation or acronym (e.g. see claim 2), the inclusion of parentheses for phrases (e.g. see sequence identifiers), raises uncertainty as to whether the feature in the parentheses is optional or always present. For example, is the limitation met with cytolysin that is similar to, but not identical to SEQ ID NO:3; or is the limitation met with a protein comprising SEQ ID NO:3 but that is not identified as a cytolysin; or is the limitation only met by the use of cytolysin consisting exactly of SEQ ID NO: 3? In other words is the sequence in paratheses required or merely exemplary? Thus, clarification is still required to remove scope ambiguity and ascertain the metes and bounds of these claims.
The term “avidin-like” in claim 4 and claim 11 is a relative term which renders each claim indefinite. The term “avidin-like” 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. In other words, how much like avidin does the protein need to be to be included vs. excluded. Thus, clarification is still required.
Other dependent claims do not clarify the issues identified above; therefore, clarification is required to ascertain the metes and bounds of these claims.
Applicant’s Arguments and Response to Arguments
7. All of Applicant’s arguments have been considered but were not deemed persuasive; accordingly, the rejection is maintained for reasons of record. For example:
With regards to the argument that “the PTO acknowledges that the inclusion of parathesis for phrases (e.g. sequence identifiers) is appropriate”; see Remarks, page 10, the Office disagrees (i.e. the Office did not state this) and, in contrast, actually stated that the inclusion of parentheses for phrases including sequence identifiers raises uncertainty (see page 3 of the Non-final Office Action filed 08/28/25). Therefore, this argument is not persuasive because it is not an accurate reflection of the rejection, and clarification is still required.
With regards to the argument that the term "avidin-like" is well known to those of skill in the art, as evidenced by the as-filed application at paragraphs [0161] and [0178], with reference to Lee et al., "A Rhizavidin Monomer with Nearly Multimeric Avidin-Like Binding Stability Against Biotin Conjugates," Angew Chem. Int. Ed. Engl. 55:3393-3397 (2016); the Office disagrees and maintains that the term in relative because it is unclear what is included and what is excluded (i.e. how much “alike” does the protein need to be to be included?). Thus, this argument is not persuasive because neither of paragraphs [0161] or [0178], or the reference explicitly defines what is, and what is, not encompassed by the term “avidin-like” (i.e. the reference gives an example, but it is not all inclusive). Thus, clarification is still required.
Therefore, all of Applicant’s arguments have been considered but were not deemed persuasive; accordingly, the rejection is maintained for reasons of record.
New Rejections Necessitated by Applicant’s Amendments
New Rejection: Claim Rejections - 35 USC § 112
8. 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.
9. Claims 1-6, 11 and 44 are rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention.
Newly amended claim 1 is indefinite based on the newly added phrase “…at least a portion of…” because the term “portion” 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. In other words, how much of the outer scaffold protein is included and/or excluded? Is any single amino acid (i.e. a portion of a protein) sufficient? Is less than a single amino acid also encompassed? Thus, clarification is required.
The term “derivatives” in newly amended claims 4 and 11 is a relative term which renders each claim indefinite. The term “derivative” 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. In other words, to what degree of derivatization is included and/or excluded? Thus, clarification is required to remove scope ambiguity.
Other dependent claims do not clarify the issues raised above; therefore, clarification is required to ascertain the metes and bounds of these claims.
Allowable Subject Matter
10. Claims 7-9, 12-18, and 45 are allowed.
11. Claims 1-6, 10-11, and 44 remain rejected.
Conclusion
12. Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
13. 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.
14. Any inquiry concerning this communication or earlier communications from the examiner should be directed to MARY MAILLE LYONS whose telephone number is (571)272-2966. The examiner can normally be reached on Monday-Friday 8 am to 5 pm 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, Dan Kolker can be reached on (571)-272-3181. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MARY MAILLE LYONS/Examiner, Art Unit 1645
March 23, 2026