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 with traverse of Group I, claims 1-7 and 11-13, and the species of “live viral vaccine, a live-attenuated viral vaccine”, in the reply filed on May 20, 2026 is acknowledged. In view of the art cited below, the species election requirement is hereby withdrawn.
Regarding the invention election, the traversal is on the ground(s) that no undue burden would arise in searching all the claims. (Remarks, 6, May 20, 2026.) This is not found persuasive because even though inventions are related the claims are directed to two inventions that fall in two different classes, which require different searches. The examination burden arises because searching for the stabilized composition comprising a viral vaccine or vector does not necessarily encompass the aspects of the methods of producing the same, recited in the claims and disclosed in the application.
The requirement is still deemed proper and is therefore made FINAL.
Claims 15, 16, 19, 23, 24, 28, 30, and 31 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on May 20, 2026.
Drawings
The drawings are objected to because Figures 1, 2, 12 contain illegible text. Figures 5-9, 13, 19, and 20 might contain text but the quality of reproduction renders any text and the significance of the drawings unintelligible. 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.
Claim Objections
Claim 1 is objected to because of the following informalities: a comma or some notation is needed after “vector” (line 3) to clearly indicate that the composition comprises (a) one or more of a live-attenuated viral vaccine,…, or a viral vector”, and (b) a Metal Organic Framework encapsulating (a). Appropriate correction is required.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
(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.
Claim(s) 1, 3-7, 11, and 13 are rejected under 35 U.S.C. 102(a)(1) as being clearly anticipated by Luzuriaga (Luzuriaga, M.A., et al., Enhanced Stability and Controlled Delivery of MOF-Encapsulated Vaccines and Their Immunogenic Response In Vivo, ACS Appl. Mater. Interfaces 2019, 11, 9740−9746).
Regarding claims 1, 7, 11, and 13, Luzuriaga teaches tobacco mosaic virus (TMV) encapsulated in a shell of zeolitic imidazolate framework-8 (TMV@ZIF), which “enhanced thermal and chemical stability to the conformational structure of the encapsulated viral nanoparticle” (abstract; p.9744 left col.). “The ZIF-8 shells are exceptionally easy to synthesize on proteins, their composites are formed in a few seconds, and are ready to use within hours.” (P.9743 rt. col.). TMV remained replication competent (Fig.2 and accompanying text, p.9742). For experimental application the TMV@ZIF composite was provided in phosphate buffer or ultrapure water (p.8744 left col.), i.e., excipients. “The morphology of TMV@ZIF is clearly different from the common rhombic dodecahedral native ZIF-8 crystals.” (p.9741 rt. col.; Fig 1(a)). In other words the TMV@ZIF composite is non-crystalline or “amorphous” as in claim 11.
Regarding claims 4-6 which recite stability and replication capacity of the encapsulated virus over 12 weeks, it is noted that for product claims, “when the structure recited in the reference is substantially identical to that of the claims, claimed properties or functions are presumed to be inherent”. MPEP §2112.01(I). Here Luzuriaga’s TMV@ZIF composite remained virulent after 10 days. Although Luzuriaga does not discuss the results after 12 weeks, because its TMV@ZIF is identical to that in claim 1, the claimed properties or functions in claims 4-6 are presumed to be inherent.
Claim(s) 1-7, 12, and 13 are rejected under 35 U.S.C. 102(a)(1) as being clearly anticipated by Gassensmith (WO 2021/097194 A1; priority to 11/14/2019).
Gassensmith teaches “pharmaceutical compositions comprising a) a therapeutic agent; b) a metal-organic framework (MOF) or a coordination polymer; and c) a pharmaceutically acceptable polymer; wherein the therapeutic agent is encapsulated within the metal-organic framework or coordination polymer to form an encapsulated therapeutic agent, and wherein the encapsulated therapeutic agent is further encapsulated, entrapped, embedded, dispersed within, or complexed to the pharmaceutically acceptable polymer” (abstract; claims 1, 2, 4-6, 15; see Fig.2 and accompanying text re:TMV@ZIF). The MOF includes zeolitic imidazolate framework (ZIF), such as ZIF-8 (Example 1 p.34) . “In some embodiments, the vaccine is an inactivated vaccine or a live-attenuated vaccine.” (P3 lines 13-22 ; claim 15). “[I]f local delivery to the lungs is desired the therapeutic compound may be administered by inhalation in a dry-powder or aerosol formulation.” (P.21 lines 28-29 (emphasis added)). Various excipients are suitable depending on the route of administration (pp.19-21).
Regarding claims 4-6 which recite stability and replication capacity of the encapsulated virus over 12 weeks, it is noted that for product claims, “when the structure recited in the reference is substantially identical to that of the claims, claimed properties or functions are presumed to be inherent”. MPEP §2112.01(I). Although Gassensmith does not discuss the results after 12 weeks, because its encapsulated therapeutic agent is identical to that in claim 1, the claimed properties or functions in claims 4-6 are presumed to be inherent.
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to H. S. PARK whose telephone number is (571)270-5258. The examiner can normally be reached on weekdays.
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/H. SARAH PARK/ Primary Examiner, Art Unit 1614
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