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 .
Rejections Necessitated by Amendment
Claim Rejections - 35 USC § 102
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.
Claim(s) 1-3, 5, 7, 8, 13, 16, 19, and 23-24 is/are rejected under 35 U.S.C. 102a1 as being anticipated by Kwong et al. (US20160046675).
For claim 1, 8, 13, 16, and 19, Kwong et al. teach RSV F with the 4 recited mutations (known in the art as DS-CAV1 or DSCAV1)(para 38). For claims 1 and 8, the RSV F can be equivalent to SEQ ID# 5 (see attached sequence comparison, the specification defines equivalent to be at least 70% identity, see para 85 and 86 of the specification). The teaching s include that the RSV F is an RNA, DNA, and mRNA (para 213 and 471). For claim 2, the fusion peptide can be can be included (para 890) and the heptad repeats are part of the natural F. For claim 3, the RSV F can additionally have a 486H mutation (para 41). For claim 5, it can have a trimerization domain on the C-terminus (Figure 44, foldon). For claim 7, the RSV F can have a p27 (also known as pep27) (para 217).
For claims 23-24, Kwong et al. teach a method of producing RNA, inherently including transcription reagents as in claim 24, as shown in Figure 31A where stabilized RSV F clones are expressed to make the protein.
Thus, Kwong et al. anticipates the claimed invention.
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) 9, 12, 18, 21-22, and 25-29 are rejected under 35 U.S.C. 103 as being unpatentable over Kwong et al. (US20160046675) as applied to claims 1, 3, 7, 13, 16, 19, and 23-24 above, and further in view of Tang et al. (US12029786) and Lutz (US20210170017A1).
Kwong et al. has been discussed above.
Kwong et al. does not teach RNA vaccines or SEQ ID# 96.
For claims 1 and 29, Tang et al. teach that mRNA vaccines against infectious pathogens have been shown to induce potent T cell and humoral responses (column 2, lines 40-45) and for claim 9, that mRNA constructs contain 3’UTR, 5’UTR, and a polyA tail (Figure 1). For claim 12, the RNA can be modified (col 3, lines 16-20). For claims 21-22 and 26, the mRNA con be formulated with pharmaceutically acceptable carriers (abstract).
For claim 18, Lutz teach sequence ID# 12469 that is at least 80% identical to seq ID# 96.
For claim 25, the RNA was isolated (Example 1).
For claims 27-28, the mRNA can be formulated with HK polymers that form nanoparticles (col 3, lines 39-43).
One of ordinary skill in the art before the effective filing date would have been motivated modify the method of Tang et al. to use the RNA based on the RSVF of Kwong et al. because the mRNA vaccine has been shown to induce a strong immune response as taught in Tang et al. One of ordinary skill in the art before the effective filing date would have had the expectation of success knowing that mRNA system works to induce an immune response and that the RSV F protein is known to be a good immunogen. One of ordinary skill in the art before the effective filing date would have had the ability to choose any RSV F sequence and use the one of Lutz and would have had the expectation of success knowing that mRNA system works to induce an immune response and that the RSV F protein is known to be a good immunogen.
Allowable Subject Matter
Claims 11, 14 and 17 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims. SEQ ID#s 95-97 are free of the prior art.
Conclusion
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).
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MYRON G HILL whose telephone number is (571)272-0901. The examiner can normally be reached Mon-Fri.
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, Janet Andres can be reached at 571-272-0867. 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.
MYRON G. HILL
Examiner
Art Unit 1671
/M.G.H/Examiner, Art Unit 1671
/Shanon A. Foley/Primary Examiner, Art Unit 1671