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 .
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.
(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, 5-8, 10-11, 15, 21-22, 25, 28, 36, 59, 69, 71-74 is/are rejected under 35 U.S.C. 102a1 as being anticipated by Rauch et al. (US20190125857).
Claim(s) 1, 3, 5-8, 10-11, 15, 21-22, 25, 28, 36, 59, 69, 71-74 is/are rejected under 35 U.S.C. 102a2 as being anticipated by Rauch et al. (US20190125857).
For claim 1, 22, and 25, Rauch et al. teach a VP1 mRNA that is at least 80% identical to SEQ ID#1 (claims 1, 12, 15, and SEQ 22824 is at least 80% identical to SEQ ID# 1, see sheet) and can comprise 1-methyl-pseudouridine (para 299). For claim 3, it can include heterologous 3’ and 5’ UTRs (claims 22 and 31). For claims 5-8, 10-11, 15, and 21, it can include a N7-Methyl-G(3’OMe)ppp and poly(A) and Poly(C), each tail between 10-100 and a stem loop (claim 36 and para 24). For claim 28, it can be a composition with a pharmaceutically acceptable carrier (claim 43). For claims 36 and 59, the composition of 28, mRNA is encapsulated with one or more cationic or polycationic compounds to make a vaccine (claim 43 and para 952).
For claim 69, the mRNA can be administered to treat a disorder, including norovirus (claims 73 and 74). For claim 71, the nucleic acid can be can be in a vector encoding the mRNA (para 78). For claim 72, it can be in a host cell (para 712). For claim 73, the polypeptide encoded by the mRNA (claim 57). For claim 74, the mRNA was expressed to make synthetic VLPs (Example 4.1 and Figure 4).
Thus, Rauch et al. anticipate 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) 4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Rauch et al. as applied to claims 1, 3, 5-8, 10-11, 15, 21-22, 25, 28, 36, 59, 69, and 71-74 above, and further in view of Bicknell et al. (20220251577).
Rauch et al. is discussed above.
Rauch et al. do not teach SEQ ID#6
Bicknell et al. teach a UTR comprising SEQ ID# 6.
One of ordinary skill in the art before the effective filing date would have been able to recognize and choose from art known sequences. One of ordinary skill in the art before the effective filing date would have been motivated and had the expectation of success knowing that functionally and structurally related sequences that are known to work can be exchanged to achieve the same functionality.
Thus, it would have been prima facie obvious to modify the mRNA of Rauch et al. with the UTR of Bicknell et al. with the expectation of success.
Claim(s) 16 and 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Rauch et al. as applied to claims 1, 3, 5-8, 10-11, 15, 21-22, 25, 28, 36, 59, 69, and 71-74 above, and further in view of Smith et al. (US11987791B2).
Rauch et al. is discussed above.
Rauch et al. do not teach SEQ ID#7
Smith et al. teach a UTR comprising SEQ ID# 7.
One of ordinary skill in the art before the effective filing date would have been able to recognize and choose from art known sequences. One of ordinary skill in the art before the effective filing date would have been motivated and had the expectation of success knowing that functionally and structurally related sequences that are known to work can be exchanged to achieve the same functionality.
Thus, it would have been prima facie obvious to modify the mRNA of Rauch et al. with the UTR of Smith et al. and have the expectation of success.
Claim(s) 16 and 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Rauch et al. as applied to claims 1, 3, 5-8, 10-11, 15, 21-22, 25, 28, 36, 59, 69, and 71-74 above, and further in view of Ramunas et al. (20220347112).
Rauch et al. is discussed above.
Rauch et al. do not teach SEQ ID# 8
Ramunas et al. teach a UTR comprising SEQ ID# 8.
One of ordinary skill in the art before the effective filing date would have been able to recognize and choose from art known sequences. One of ordinary skill in the art before the effective filing date would have been motivated and had the expectation of success knowing that functionally and structurally related sequences that are known to work can be exchanged to achieve the same functionality.
Thus, it would have been prima facie obvious to modify the mRNA of Rauch et al. with the UTR of Smith et al. and have the expectation of success.
Claim(s) 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Rauch et al. as applied to claims 1, 3, 5-8, 10-11, 15, 21-22, 25, 28, 36, 59, 69, and 71-74 above, and further in view of Bicknell et al. (20220251577) and Smith et al. (US11987791B2).
Rauch et al. is discussed above.
Rauch et al. do not teach SEQ ID# 6 and 7.
Bicknell et al. and Smith et al. are discussed above and teach UTRs comprising SEQ ID# 6 and 7.
One of ordinary skill in the art before the effective filing date would have been able to recognize and choose from art known sequences. One of ordinary skill in the art before the effective filing date would be motivated and have had the expectation of success knowing that functionally and structurally related sequences that are known to work can be exchanged to achieve the same functionality.
Thus, it would have been prima facie obvious to modify the mRNA of Rauch et al. with the UTRs of Bicknell et al. and Smith et al. and have the expectation of success.
Claim(s) 33 is/are rejected under 35 U.S.C. 103 as being unpatentable over Rauch et al. further in view of Bicknell et al. (20220251577) and Smith et al. (US11987791B2) as applied to claims 19 above.
Rauch et al., Bicknell et al. and Smith et al. are discussed above.
Rauch et al. additionally teach sequences 80% or more identical to SEQ ID# 2-5 (see sheets and that compositions can contain 5 types of VP1 (col 98, lines 45 and 65).
One of ordinary skill in the art before the effective filing date would have been able to choose sequences art known sequences to use in compositions and vaccines. One of ordinary skill in the art would be motivated to make a because of health impact and because there are multiple types and there is antigenic shift (col 1-2). One of ordinary skill in the art before the effective filing date would have had the expectation of success knowing that the other sequences are known and that making multivalent vaccines.
Thus, it would have been prima facie obvious to modify the mRNA of Rauch et al., Bicknell et al. and Smith et al. to contain multiple different VP1s and have the expectation of success.
Conclusion
Cited as of note: US11141474B2 is the issued patent of the Rauch et al. PGPub cite above.
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MYRON G. HILL
Examiner
Art Unit 1671
/M.G.H/Examiner, Art Unit 1671
/Shanon A. Foley/Primary Examiner, Art Unit 1671
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