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 .
Claim Rejections - 35 USC § 103
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 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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over TRILINK BIOTECHNOLOGIES, INC. WO 2017/053297 A1 (TRILINK).
Claim 12 is drawn to an RNA analog capped with a 5'Cap analog having a Cap2 structure, wherein the RNA analog comprises the structure of formula (II).
TRILINK relates to methods and compositions for synthesizing 5'Capped RNAs wherein the initiating capped oligonucleotide primers have the general form m7Gppp[N2'Ome]n[N]m wherein m7G is N7-methylated guanosine or any guanosine analog, N is any natural, modified or unnatural nucleoside, "n" can be any integer from 0 to 4 and "m" can be an integer from 1 to 9 (Abstract). TRILINK teaches that messenger RNA (mRNA), encoding physiologically important proteins for therapeutic applications, has shown significant advantages over DNA-based plasmid and viral vectors for delivering genetic material [0004]. The most important of these advantages are:
(i) high level of safety (reduces potential genome damage from viral or plasmid integration),
(ii) mRNA delivery results in immediate protein expression (unlike delayed responses that generally occur with plasmids),
(iii) mRNA allows for robust dose-dependent control over expression of proteins and
(iv) the simplicity of large scale synthesis of mRNAs compared to manufacturing of plasmid and viral vectors.
Figure 10H shows the structure of initiating capped oligonucleotide primers used in examples according to Formula I wherein: Bi is adenine; B2 is guanine; Bio is guanine; M is 0; L is 1 ; qi is 1; q2 is 1; q3 through q9 are 0; Ri is H; R2 is H; R3 is O-methyl; X1 is 0; X2 is 0; X4 is 0; X5 is 0; Xu is 0; Yi is OH; Y2 is OH; Y4 is OH; Y5 is OH; Y13 is OH; Z0 is 0; Z1 is 0; Z2 is 0; Z4 is 0; Z5 is 0; Z6 is 0; Z22 is 0; R4 is O-methyl; R5 is O-methyl [0042].
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The initiating capped oligonucleotide primer of TRILINK (e.g., m7GpppA2OmepG2OmepG) differs from the instantly claimed capped RNA analog in that the primer of TRILINK does not contain an RNA chain; however, this deficiency would have been obvious as TRILINK relates to methods and compositions for synthesizing 5'Capped RNAs. Thus, TRILINK would have reasonably suggested an RNA analog as depicted in Figure 10H wherein an RNA chain is extended from the G residue. “[I]n considering the disclosure of a reference, it is proper to take into account not only specific teachings of the reference but also the inferences which one skilled in the art would reasonably be expected to draw therefrom.” In re Preda, 401 F.2d 825, 826, 159 USPQ 342, 344 (CCPA 1968). See MPEP 2144.01.
Conclusion
Claims 1-14 are pending. Claim 12 is rejected. Claims 1-11 and 13-14 are allowed.
The following is a statement of reasons for the indication of allowable subject matter: TRILINK BIOTECHNOLOGIES, INC. WO 2017/053297 A1 (TRILINK) is representative of prior art. TRILINK does not teach or suggest a compound of instant formula (I). It would not have been obvious to modify a compound of TRILINK in a manner that would produce an analog of instant formula (I).
Contacts
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PATRICK T LEWIS whose telephone number is (571)272-0655. The examiner can normally be reached Monday to Friday, 10 AM to 4 PM EST (Maxi Flex).
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Shaojia Jiang can be reached at (571) 272-0627. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/PATRICK T LEWIS/Primary Examiner, Art Unit 1691
/PL/