?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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 9/8/25 has been entered.
Claim Rejections - 35 USC § 112
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.
Claim 18 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.
Claim 18 depends on canceled claim 17 and thus the metes and bounds cannot be determined.
Claim Rejections - 35 USC § 103
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.
Claim(s) 4-6, 9, 11, 13-16, and 19-20 are rejected under 35 U.S.C. 103 as being unpatentable over Chang (US7662394), Tröße et al. (Gene Regulation and Systems Biology 2007:1 303–312) and Camacho et al. (Detection of Autochthonous Zika Virus Transmission in Sincelejo, Colombia. Emerging Infect. Dis 2016; 22(5):927-929).
For claims 5, 9, and 11, Chang teach a nucleic acid construct comprising the prM/E not limited to specific virus (claim 1 is “flavivirus” generic. figures 2 and 7, and claim 2 lists many alternative flavivirus). Heterologous secretion sequence (the “pr”, claim 3 etc.) is taught. Adjuvants can be included in the compositions (column 17, line 35). For claim 11, Chang teach the composition of claim 5 plus adjuvants including alum (para spanning cols 19-20).
For claims 14, 15, 19, and 20, Chang teach vaccines that when administered lead to protective immunity (col 13, lines 28-33), the vaccine can be administered subcutaneously (col 20, line 24), and teach female mammals (example 5).
While Chang does not teach lipid bi-layer, both the prior art and the invention produce subviral particles in a similar manner and there are no extra steps recited in the instant application thus lipid bilayers are inherently taught.
Chang does not teach the recited heterologous secretion sequence Oikosin.
For claim 5, Tröße et al. teach that oikosin 1 is an effective secretion signal and that “The results described here provide substantial support to our previous observations which suggested that the choice of the signal peptide is imperative when aiming to achieve optimal synthesis and secretion of a recombinant protein using transfected mammalian cells.” (abstract).
One of ordinary skill in the art before the effective time of filing would know signal sequences are used and can be optimized, see Chang Example 18 “Signal peptide differences in various plasmid constructs can account, at least in part, for the difference in protein translocation, cleavage site presentation and correct topology, thus, prM and E secretion and VLP formation. The modulation or optimization of these attributes can be improved by selection or use of signal sequences with properties that impart the desired characteristics.”
One of ordinary skill in the art before the effective time of filing would motivated to optimize the production of secreted proteins as suggested by Tröße et al. to increase the efficiency of protein production for the desired use because more protein can be made in smaller batches thus saving time and/or resources.
Chang and Tröße et al. are discussed above.
Chang and Tröße et al. do not teach Zika virus, or specific Zika sequence.
For claims 4-6, 9, and 14, Camacho et al. is drawn to a study of Zika virus, a Flavivirus, isolated in Columbia in 2015 (see page 928). In particular, the isolated virus was sequenced to determine relatedness to previously isolated Zika virus (see Figure at page 928). Although the sequence of the virus wasn’t presented in the publication, it was simultaneously submitted to the NCBI database as KU646827 (previously provided in 11/9/18 action of the parent listed on the IDS and cited) and in the alignment, the sequence is 100% identical to that of Seq. Id. No. 1. Thus, Camacho et al. teaches a Zika virus comprising a sequence that is greater than 80% identity to at least Seq. ID. No. 1. Camacho et al. teach that Zika infection is associated with congenital malformation (first paragraph).
One of ordinary skill in the art before the effective time of filing would not be concerned with capsid protein packaging infectious RNA because there is no full length infectious flavivirus nucleic acid in the vector.
One of ordinary skill in the art before the effective time of filing would have known that Zika virus was an emerging viral pathogen that was associated with birth defects when infecting women and one would have been motivated to vaccinate human females to protect them.
One of ordinary skill in the art before the effective time of filing would have known that Zika virus was a flavivirus and been able to choose art known vaccine strategies used for the other flavivirus to make a vaccine.
One of ordinary skill in the art before the effective time of filing would have known would have been able to choose from art known Zika virus prM/E sequences as Chang is not limited to just one flavivirus to make and use the invention.
Thus, it would have been prima facie obvious before the effective time of filing to use the flavivirus vaccine of Chang and Tröße et al. with the Zika virus of Camacho et al. with the expectation of success knowing that the virus is related and the strategy has been used before.
Applicant argues that Chang pertains to JE prM/E, and that oiksin 2-7 were extremely ineffective. Applicant argues Camacho et al. in the second 103 rejection (now incorporated here) That it does not cure the defects of the prior two references.
Applicant’s arguments have been fully considered and not found persuasive.
In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., JE capsid) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
For the argument about Chang for not teaching Zika virus, Zika was not recognized as a concern at the time of filing of Chang (2002) and that Zika Virus is a related flavivirus and has the same related types of genome and proteins encoded. Chang includes any flavirus as claim 1 is not limited to a specific prM/E. There is a list of known at the time medically important flavivirus in claim 2.
Tröße et al. recognizes the ineffectiveness of some of the oikosin secretion signals but does point out one that works. Tröße et al. teach one would optimize for expression (abstract). One of ordinary skill in the art would be motivated to use the secretion signal that is shown to be most effective. Tröße et al. point out that oikosin 1 was most effective. Just because Tröße et al. teach alternatives that are less effective, Tröße et al. point out one that is very effective. One of ordinary skill in the art would be able to choose oikosin 1 from the teaching in the art.
For the argument on Camacho et al., the missing elements of Chang and Tröße et al. are discussed by the modified rejection and the response to applicant’s earlier arguments.
Conclusion
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MYRON G. HILL
Examiner
Art Unit 1671
/M.G.H/Examiner, Art Unit 1648
/Shanon A. Foley/Primary Examiner, Art Unit 1671