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 .
DETAILED ACTION
1. Claim 2 is amended. Claims 7-10, 19-20, 22, 23, 25, 26 are canceled. Claims 18, 21, 24 are withdrawn. Claims 1-6, 11-17 are under consideration.
2. Due to the new rejections below, this Action is a Non-Final Action.
Declaration Submission
3. The Declaration under 37 CFR 1.130(a) filed 10/30/2025 is insufficient to overcome the rejection of claims 1-5, 11, 16, 17 based upon Xie et al. in view of Whitehead et al. (cited below) as set forth in the last Office action because: the Declaration does not provide a reasonable explanation of the presence or involvement of the additional authors (See MPEP 717.01(a)(1)).
Claim Objections
4. (new objection) Claim 11 is objected to because of the following informalities:
For improved clarity, it is suggested claim 11 recite language such as “mCherry ZIKV strain construct”, as opposed to reading upon a naturally occurring strain (See [0037] of the instant specification).
Appropriate correction is required.
Claim Rejections - 35 USC § 112
5. (previous rejection, withdrawn) Claim 2 was rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and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.
Applicant contends: the claim has been clarified.
In view of applicant’s amendments, the rejection is withdrawn.
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)(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.
6. (new rejection) Claims 1-5, 16, 17 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Woodson et al. (WO2017156511A1)(See PTO-892: Notice of References Cited).
See claims 1-5, 16, 17 as submitted 10/30/2025.
Woodson et al. teaches: live attenuated Zika Virus vaccine (title); attenuated Zika viruses and vaccines (abstract); including deletions introduced into the 3’ UTR ([0032]; [0031] of provisional application 62/307,170)(as recited in claim 1); including Δ30 deletion ([0149]; [0035] of provisional application 62/307,170)(as recited in claims 2, 3, 4, 5)(wherein “is” in claims 4, 5 is interpreted as “comprising” (See MPEP 2111)); including in carrier as immunogenic compositions [0111]; [0105] of provisional application 62/307,170)(as recited in claim 16); parenteral administration ([0184] of provisional application 62/307,170)(as recited in claim 17).
Thus, Woodson et al. anticipates the instant claims.
Claim Rejections - 35 USC § 103
7. (previous rejection, withdrawn) Claims 1-5, 11, 16, 17 were rejected under 35 U.S.C. 103 as being unpatentable over Xie et al. ("Understanding Zika Virus Stability and Developing a Chimeric Vaccine through Functional Analysis," mBio 8:e02134-16 (2017))(cited in applicant's IDS submitted 10/5/2023) in view of Whitehead et al. (US20100104598)(cited in applicant's IDS submitted 10/5/2023).
Applicant contends: a Declaration under 37 CFR 1.130(a) is submitted; Xie et al. is excluded as prior art; Whitehead et al. teaches 3’UTR deletions for DENV serotypes; the art provides no suggestion to apply DENV-specific 3’ UTR deletions to native ZIKV.
See above with respect to the submitted Declaration. Upon further consideration, applicant’s arguments are considered and found persuasive as to the teachings of Whitehead et al., and the rejection is withdrawn.
8. (previous rejection, withdrawn) Claim 6 was rejected under 35 U.S.C. 103 as being unpatentable over Xie et al. in view of Whitehead et al. as applied to claims 1-5, 11, 16, 17 above, and further in view of Despres et al. (U.S. Patent No. 10849943; previously cited).
In view of the withdrawal of the rejection over Xie et al. in view of Whitehead et al. on which the instant rejection depends, the instant rejection is also withdrawn.
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.
9. (new rejection) Claims 1, 16, 17 are rejected under 35 U.S.C. 103 as being unpatentable over Zeng et al. (WO0014245)(See PTO-892; Notice of References Cited).
See claims 1, 16, 17 as submitted 10/30/2025.
Zeng et al. teaches: replication-defective flaviviruses (abstract); mutant flaviviruses useful as vaccines (abstract); including construction and propagation of flaviviruses that possess 3’-noncoding regions altered to prevent or limit reproduction (abstract); including producing mutant flaviviruses for use as vaccines (abstract); wherein replication defective vaccines are often live, attenuated infectious viruses (p. 3)(as recited in claim 1); wherein mutants (dengue) may be used as live attenuated vaccines (p. 5); wherein viruses contemplated for use include Zika (p. 3)(as recited in claim 1); wherein flavivirus genomes include 3’ NCRs and form stem and loop structures (p. 4); evidence suggests that the 3’ SL plays a crucial role in flavivirus replication; including deletions of 3’NCR nucleotide sequences upstream from the 3’SL- in a DEN4 infectious cDNA were relatively well tolerated, whereas a deletion that extended into the nucleotides sequence … was lethal for DEN4 replication (p. 22); deletion of 3’NCR nucleotide sequences … were lethal for DEN4 virus replication (p. 4); the 3’-SL structure in flavivirus RNA is well conserved among species; nucleotide sequences of the loop segments are relatively well conserved (p. 5); any member of the Flaviviridae containing a 3’SL structure may be mutagenized … to produce .. mutant virus (p. 5); with carriers (p. 7)(as recited in claim 16); subcutaneous administration (p. 7)(as recited in claim 17).
In view of such teachings or suggestions as to mutating flavivirus, including Zika virus, an embodiment as recited in the instant claims is obvious in view of Zeng et al. One of ordinary skill in the art would have been motivated and had a reasonable expectation of success in arriving at the instant claims in view of Zeng et al.
Therefore the invention as a whole would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention.
10. (new rejection) Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Woodson et al. as applied to claims 1-5, 16, 17 above, and further in view of Jones et al. (U.S. Patent No. 10835596)(See PTO-892: Notice of References Cited).
See claim 6 as submitted 10/30/2025.
See the teachings of Woodson et al. above.
Woodson et al. does not teach: comprising a 3' UTR having at least 80%, at least 85%, at least 90%, at least 95%, at least 98%, at least 99%, or 100% identity to the nucleic acid sequence of SEQ ID NO: 2 (elected species).
Jones et al. teaches: compositions and methods for flavivirus vaccination, including Zika virus SEQ ID NO: 21, a known Zika virus strain Haiti/1225/2014, comprising sequence with 93% identity with instant SEQ ID NO: 2 (See Result 19 of STIC Sequence Search
Result 20250604_181908_us-18-210-829b-2.rni in Supplemental Content Tab)
One of ordinary skill in the art would have been motivated to use sequence as taught by
Jones et al. as the virus as taught by Woodson et al. Woodson et al. teaches vaccines and using Zika virus, and Jones et al., which also teaches vaccines and use of Zika virus, teaches such a known Zika virus sequence (See MPEP 2144.06: Substituting equivalents known for the same purpose).
One of ordinary skill in the art would have had a reasonable expectation of success for
using sequence as taught by Jones et al. as the virus as taught by Woodson et al. There would have been a reasonable expectation of success given the underlying materials (Zika virus as
taught by Jones et al. and Woodson et al.) and methods are known, successfully demonstrated, and commonly used as evidenced by the applied prior art.
Therefore the invention as a whole would have been prima facie obvious to one of
ordinary skill in the art before the effective filing date of the claimed invention.
11. (new rejection) Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Zeng et al. as applied to claims 1, 16, 17 above, and further in view of Jones et al. (U.S. Patent No. 10835596)(cited above).
See claim 6 as submitted 10/30/2025.
See the teachings of Zeng et al. above.
Zeng et al. does not teach: comprising a 3' UTR having at least 80%, at least 85%, at least 90%, at least 95%, at least 98%, at least 99%, or 100% identity to the nucleic acid sequence of SEQ ID NO: 2 (elected species).
Jones et al. teaches: compositions and methods for flavivirus vaccination, including Zika virus SEQ ID NO: 21, a known Zika virus strain Haiti/1225/2014, comprising sequence with 93% identity with instant SEQ ID NO: 2 (See Result 19 of STIC Sequence Search
Result 20250604_181908_us-18-210-829b-2.rni in Supplemental Content Tab).
One of ordinary skill in the art would have been motivated to use sequence as taught by
Jones et al. as the virus as taught by Zeng et al. Zeng et al. teaches vaccines and using Zika virus, and Jones et al., which also teaches vaccines and use of Zika virus, teaches such a known Zika virus sequence (See MPEP 2144.06: Substituting equivalents known for the same purpose).
One of ordinary skill in the art would have had a reasonable expectation of success for
using sequence as taught by Jones et al. as the virus as taught by Zeng et al. There would have been a reasonable expectation of success given the underlying materials (Zika virus as
taught by Jones et al. and Zeng et al.) and methods are known, successfully demonstrated, and commonly used as evidenced by the applied prior art.
Therefore the invention as a whole would have been prima facie obvious to one of
ordinary skill in the art before the effective filing date of the claimed invention.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
12. (previous rejection, withdrawn as to claims 13, 15; maintained as to claims 1-6, 11, 12, 14, 16, 17) Claims 1-6, 11, 12, 14, 16, 17 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-16 of U.S. Patent No. 11730801.
See claims 1-6, 11, 12, 14, 16, 17 as submitted 10/30/2025.
Applicant contends: the rejection should be deferred until allowable subject matter is obtained.
Upon further consideration, the rejection is withdrawn as to claims 13, 15.
See the rejection as recited in the previous Office Action.
The rejection is maintained for reasons of record.
Conclusion
13. Claims 13, 15 are objected to for depending on rejected claims.
14. No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to M FRANCO G SALVOZA whose telephone number is (571)272-4468. The examiner can normally be reached M-F 8:00 to 5:00.
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 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.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/M FRANCO G SALVOZA/Primary Examiner, Art Unit 1672